Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 4:41 PM
Study NCT ID:
NCT01394861
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-04', 'studyFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2011-07-14', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease of the procedure', 'timeFrame': '30 days', 'description': 'The ease of the procedure (grasping, retraction, triangulation), time required for mucosal cutting and submucosal dissection'}], 'secondaryOutcomes': [{'measure': 'Completeness of the Procedure', 'timeFrame': '30 days', 'description': 'Completeness of the procedure is evaluated during the procedure by endoscopy and gross examination of the resected specimen followed by histopathological examination.'}, {'measure': 'Immediate Procedure Related Complications', 'timeFrame': '30 days', 'description': 'Bleeding or Perforation during and immediately after the procedure'}, {'measure': 'Delayed Procedure Related Complications', 'timeFrame': '30 days', 'description': 'Any complications (Delayed Bleeding or Perforation) related to the procedure up to thirty days post procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endoscopic Submucosal Dissection', 'ESD', 'EMR', 'Early Gastric Cancer', 'Flexible Endoscopic Robotic System', 'Master Slave Robot', 'Ease & Safety of ESD by Flexible Master Slave Robotic System'], 'conditions': ['Endoscopic Submucosal Dissection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility, ease and safety of flexible endoscopic robotic system to treat early gastric cancer in humans.', 'detailedDescription': "Aim:\n\nTo evaluate the feasibility and safety of Endoscopic Submucosal Dissection (ESD) using Master Slave Endoscopic Robotic System in humans.\n\nMaterial and Methods:\n\nTo assess the feasibility and safety of ESD in humans, 3 patients with early gastric cancer or sessile polyp in the stomach with no evidence of involvement of deeper layer will be included in the study. The depth of involvement is evaluated by endoscopic ultrasound. An informed consent about the nature of the procedure, complications and the need for surgery will be explained to the patient. The master slave robot system (Human master robotic interface, telesurgical workstation and slave manipulator) and forward viewing therapeutic endoscope with 2 operating channels (GIF -2T160) will be used. The master controller controls the slave manipulator with electrical cables through a software interface. The slave manipulator in turn controls the end effectors (Monopolar 'L' hook and grasper) through cables passed through the two operating channels of the endoscope. The master slave robot system will be set up by the engineers from the Nanyang Technological University, Singapore. The endoscope will be connected to the high definition visual display and will be recorded throughout the procedure. Another high definition monitor will be set up for the surgeon/endoscopist who will control the MASTER at the console and the movements at the console will be continuously recorded. Monopolar electrocautery (ERBE) will be set up and tested. The settings for cutting and blend will be the same as used in the conventional ESD.\n\nThe therapeutic endoscope and the end effectors will be sterilised by immersing the scope in glutaraldehyde for 30 minutes before the procedure.\n\nPatient will be kept fasting for 8 hours before the procedure. Under IV sedation, with the patient in left lateral position, end viewing diagnostic gastroscope is passed with an overtube. The lesion will be identified. Then the lesion will be marked by electrocautery (ERBE) all around. Then Gelofusine® (containing 4% succinylated gelatin, sodium hydroxide) stained with methylene blue will be injected submucosally under the lesion to create a cushion for ESD. Then IT knife is used for the mucosal cut all around the lesion. The double channel endoscope (GIF 2T160) will be exchanged through the overtube for the conventional endoscope after checking the system. Then submucosal dissection of the lesion will be performed, using the Master.\n\nThe data will be captured in the standard proforma for each patient. The endoscopic view and the external view of the MASTER will be recorded throughout the procedure.\n\nAnalysis - Efficacy and Safety outcomes:\n\nThe ease of the procedure (grasping, retraction, triangulation and complete excision), time required for mucosal cutting and submucosal dissection and completeness of the procedure will be analysed. Safety outcomes include intraoperative, immediate postoperative complications (bleeding, perforation) and the need for laparotomy will be assessed. Delayed Complications if any will be recorded for up to 30 days after the procedure.\n\nStatistical Methodology:\n\nAs this is a pilot study, no sample size calculation was done. The aim is to perform the procedure in 3 subjects. Descriptive statistics will be used to describe safety data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Early Gastric Cancer or Gastric sessile polyp with dysplasia\n\nExclusion Criteria:\n\n* Gastric Cancer with involvement of muscle layer\n* Advanced Gastric cancer'}, 'identificationModule': {'nctId': 'NCT01394861', 'acronym': 'ESD', 'briefTitle': 'Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'orgStudyIdInfo': {'id': 'AIG-GI2011-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESD using MASTER Slave Robotic System', 'interventionNames': ['Device: ESD using Master Slave Robotic System']}], 'interventions': [{'name': 'ESD using Master Slave Robotic System', 'type': 'DEVICE', 'description': 'Endoscopic submucosal dissection of early gastric cancer or broad sessile polyp using Master Slave Robotic System', 'armGroupLabels': ['ESD using MASTER Slave Robotic System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Asian Institute Of Gastroenterology India'}], 'overallOfficials': [{'name': 'Nageshwar Reddy Duvvuru, MD, DM, DSc, FAMS, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asian Institute of Gastroenterology, India'}, {'name': 'Louis Soo Jay Phee, BEng, MEng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanyang Technological University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanyang Technological University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}