Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-02 @ 6:52 AM
Study NCT ID:
NCT03977935
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2019-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Second-Generation MCCG for Upper Gastrointestinal Tract.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '1372971347@qq.com', 'phone': '15021569528', 'title': 'Investigator of Clinical Trials', 'organization': 'Changhai Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'capsule retention, aspiration of the capsule, severe choking cough and death.', 'eventGroups': [{'id': 'EG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Circumferential Visualization of the Z-line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'title': '100% of Z-line', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '≥50% of Z-line', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '<50% of Z-line', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': '0% of Z-line', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through end of examination, up to 30 minutes', 'description': 'Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\\>75%) observed; and entire Z line (100%) observed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Detection Rate of Duodenal Papilla', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 2 days after the examination', 'description': 'Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastric Examination Time (GET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.78', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '5.24', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through end of examination, up to 30 minutes', 'description': 'Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Manipulation Performance Score of the MCCG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'title': 'Fluency', 'categories': [{'measurements': [{'value': '3.04', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '4.59', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Comfortableness', 'categories': [{'measurements': [{'value': '3.16', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Stability', 'categories': [{'measurements': [{'value': '3.84', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Total score', 'categories': [{'measurements': [{'value': '10.05', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '13.28', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 10 minutes after the examination', 'description': "The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Image Quality Score (Mainly Focus on Clarity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.90', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '8.63', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 30 minutes after the examination', 'description': 'Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Images Captured for Esophagus and Z-line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'title': 'The number of images captured for esophagus', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '160.25'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '81.25', 'upperLimit': '409.25'}]}]}, {'title': 'The number of images captured for Z-line', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.75'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 30 minutes after the examination', 'description': 'The number of images captured by MCCG for esophagus and Z-line.', 'unitOfMeasure': 'images', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Lesions in Upper Gastrointestinal Tract', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'title': 'Inflammation', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Focal lesions', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'normal', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 2 days after the examination', 'description': 'calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'title': 'Gastric transit time (min)', 'categories': [{'measurements': [{'value': '53.09', 'groupId': 'OG000', 'lowerLimit': '22.88', 'upperLimit': '90.84'}, {'value': '48.35', 'groupId': 'OG001', 'lowerLimit': '19.09', 'upperLimit': '78.83'}]}]}, {'title': 'Small-bowel transit time (min)', 'categories': [{'measurements': [{'value': '327.60', 'groupId': 'OG000', 'lowerLimit': '260.73', 'upperLimit': '394.55'}, {'value': '297.22', 'groupId': 'OG001', 'lowerLimit': '239.68', 'upperLimit': '369.27'}]}]}, {'title': 'Total running time (min)', 'categories': [{'measurements': [{'value': '702.83', 'groupId': 'OG000', 'lowerLimit': '648.47', 'upperLimit': '856.10'}, {'value': '1001.99', 'groupId': 'OG001', 'lowerLimit': '774.42', 'upperLimit': '1207.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 days after the examination', 'description': 'Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cleansing Level Score of Z-line Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'title': 'No bubbles', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'A few bubbles', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Increased amount of bubbles', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Severe bubbles', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through end of examination, up to 30 minutes', 'description': 'The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Incidence of Adverse Events (The Safety of MCCG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 2 weeks after the examination', 'description': 'The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transit Time of MCCG in Esophagus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'OG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '24.75', 'upperLimit': '82.75'}, {'value': '44.5', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '107.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 days after the examination', 'description': 'Assess the transit time of MCCG in esophagus from starts take images to ends.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'FG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'The First-generation MCCG Group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'id': 'BG001', 'title': 'The Second-generation MCCG Group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.\n\nthe second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.45', 'spread': '13.51', 'groupId': 'BG000'}, {'value': '48.58', 'spread': '14.24', 'groupId': 'BG001'}, {'value': '48.51', 'spread': '13.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Indication', 'classes': [{'categories': [{'title': 'Abdominal pain or distension', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Acid reflux or nausea/vomit', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Chronic diarrhea', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Physical examination', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Helicobacter pylori (Hp) infection', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of abdominal surgery, smoking and drinking', 'classes': [{'title': 'History of abdominal surgery', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Smoking history', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Drinking history', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-01', 'size': 236962, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-13T22:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2019-06-03', 'resultsFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-06', 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circumferential Visualization of the Z-line', 'timeFrame': 'Through end of examination, up to 30 minutes', 'description': 'Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\\>75%) observed; and entire Z line (100%) observed.'}], 'secondaryOutcomes': [{'measure': 'Detection Rate of Duodenal Papilla', 'timeFrame': 'up to 2 days after the examination', 'description': 'Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained'}, {'measure': 'Gastric Examination Time (GET)', 'timeFrame': 'Through end of examination, up to 30 minutes', 'description': 'Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).'}, {'measure': 'Manipulation Performance Score of the MCCG', 'timeFrame': 'up to 10 minutes after the examination', 'description': "The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best."}, {'measure': 'Image Quality Score (Mainly Focus on Clarity)', 'timeFrame': 'up to 30 minutes after the examination', 'description': 'Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).'}, {'measure': 'The Number of Images Captured for Esophagus and Z-line', 'timeFrame': 'up to 30 minutes after the examination', 'description': 'The number of images captured by MCCG for esophagus and Z-line.'}, {'measure': 'Number of Participants With Lesions in Upper Gastrointestinal Tract', 'timeFrame': 'up to 2 days after the examination', 'description': 'calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.'}, {'measure': 'Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time', 'timeFrame': 'up to 2 days after the examination', 'description': 'Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.'}, {'measure': 'Cleansing Level Score of Z-line Area', 'timeFrame': 'Through end of examination, up to 30 minutes', 'description': 'The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.'}, {'measure': 'The Incidence of Adverse Events (The Safety of MCCG)', 'timeFrame': 'up to 2 weeks after the examination', 'description': 'The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.'}, {'measure': 'Transit Time of MCCG in Esophagus', 'timeFrame': 'up to 2 days after the examination', 'description': 'Assess the transit time of MCCG in esophagus from starts take images to ends.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SG-MCCG', 'Z-line visualization', 'Image quality', 'Gastric examination time', 'Manipulation performance'], 'conditions': ['Capsule Endoscopy']}, 'referencesModule': {'references': [{'pmid': '31981648', 'type': 'DERIVED', 'citation': 'Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.', 'detailedDescription': 'Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized.\n\nTherefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method.\n\nThis is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With or without gastrointestinal complaints\n* Scheduled to undergo a capsule endoscopy for both stomach and small bowel\n* Signed the informed consents before joining this study\n\nExclusion Criteria:\n\n* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy\n* Refused abdominal surgery to take out the capsule in case of capsule retention\n* Implanted pacemaker, except the pacemaker is compatible with MRI\n* Other implanted electromedical devices or magnetic metal foreign bodies\n* Pregnancy or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT03977935', 'briefTitle': 'The Second-Generation MCCG for Upper Gastrointestinal Tract.', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'SG-MCCG-UGT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'The first-generation MCCG group', 'description': 'The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.'}, {'type': 'EXPERIMENTAL', 'label': 'The second-generation MCCG group', 'description': 'All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.', 'interventionNames': ['Device: the second-generation MCCG']}], 'interventions': [{'name': 'the second-generation MCCG', 'type': 'DEVICE', 'description': 'Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).', 'armGroupLabels': ['The second-generation MCCG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zhuan Liao', 'investigatorAffiliation': 'Changhai Hospital'}}}}