Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-04-18 @ 10:58 AM
Study NCT ID:
NCT01892267
Status:
TERMINATED
Last Update Posted:
2017-05-17
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkhasha1@jhmi.edu', 'phone': '443-287-1960', 'title': 'Dr. Mouen Khashab', 'organization': 'Johns Hopkins Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea after tube placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting after tube placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With PEG-J Tube Migration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of placement up to 4 weeks', 'description': 'Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patency of Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'timeFrame': '2 years', 'description': 'Determine tube patency which is defined as time period between tube placement and need for re-intervention.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely, so that the appropriate follow-up data was not collected.'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Intra-procedural', 'description': 'Success of tube placement in the desired location as determined endoscopically.', 'unitOfMeasure': 'procedure', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intervention Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '28.7', 'spread': '13.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intra-procedural', 'description': 'Time required from introduction of the upper endoscope until placement of the feeding tube.', 'unitOfMeasure': 'minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Repeat Endoscopy for Tube Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'timeFrame': '2 years', 'description': 'If repeate endocopy and tube placement are needed due to clogging or retrograde migration', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely, so that the appropriate follow-up data was not collected.'}, {'type': 'SECONDARY', 'title': 'Difficulty of the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '7', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Inra-procedural', 'description': 'Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being "without difficulty" and 10 being "maximum difficulty".\n\nThe lower the score, the better the outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Quality of Life Index (GIQLI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '140'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 month', 'description': 'Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that only 5 patients had a completed GIQLI questionnaire at 3-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Short-term Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One week', 'description': 'Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Long-term Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'timeFrame': '2 years', 'description': 'Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely, so that the appropriate follow-up data was not collected.'}, {'type': 'SECONDARY', 'title': 'Direct Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'OG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'timeFrame': '2 years', 'description': 'Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc)', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely, so that the appropriate follow-up data was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'FG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled between 7/1/13 and 4/14/14 in an academic tertiary center'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-propelled PEGJ Feeding Tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'BG001', 'title': 'Standard PEGJ Feeding Tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.\n\nPEG-J placement: PEG-J placement'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.22', 'spread': '13.30', 'groupId': 'BG000'}, {'value': '52', 'spread': '10.68', 'groupId': 'BG001'}, {'value': '56.84', 'spread': '12.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gastrointestinal Quality of Life Index (GIQLI) score', 'classes': [{'categories': [{'measurements': [{'value': '78.2', 'spread': '27.1', 'groupId': 'BG000'}, {'value': '69.1', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '20.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Study was terminated prematurely as costs incurred were more than the available funds.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2013-07-01', 'resultsFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-13', 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With PEG-J Tube Migration', 'timeFrame': 'From date of placement up to 4 weeks', 'description': 'Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration', 'timeFrame': '4 weeks', 'description': 'Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement'}, {'measure': 'Patency of Feeding Tube', 'timeFrame': '2 years', 'description': 'Determine tube patency which is defined as time period between tube placement and need for re-intervention.'}, {'measure': 'Technical Success', 'timeFrame': 'Intra-procedural', 'description': 'Success of tube placement in the desired location as determined endoscopically.'}, {'measure': 'Intervention Time', 'timeFrame': 'Intra-procedural', 'description': 'Time required from introduction of the upper endoscope until placement of the feeding tube.'}, {'measure': 'Time to Repeat Endoscopy for Tube Replacement', 'timeFrame': '2 years', 'description': 'If repeate endocopy and tube placement are needed due to clogging or retrograde migration'}, {'measure': 'Difficulty of the Procedure', 'timeFrame': 'Inra-procedural', 'description': 'Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being "without difficulty" and 10 being "maximum difficulty".\n\nThe lower the score, the better the outcome.'}, {'measure': 'Gastrointestinal Quality of Life Index (GIQLI) Score', 'timeFrame': '3 month', 'description': 'Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms'}, {'measure': 'Short-term Complications', 'timeFrame': 'One week', 'description': 'Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week.'}, {'measure': 'Long-term Complications', 'timeFrame': '2 years', 'description': 'Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention.'}, {'measure': 'Direct Cost', 'timeFrame': '2 years', 'description': 'Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PEGJ', 'PEG-J', 'Percutaneous Endoscopic Gastrostomy', 'Feeding tube', 'Gastroparesis', 'Acute pancreatitis', 'Stroke', 'Respiratory failure', 'GERD', 'Balloon', 'Self-propelled'], 'conditions': ['Feeding Tube']}, 'referencesModule': {'references': [{'pmid': '23622977', 'type': 'BACKGROUND', 'citation': 'Kim KJ, Victor D, Stein E, Valeshabad AK, Saxena P, Singh VK, Lennon AM, Clarke JO, Khashab MA. A novel ballooned-tip percutaneous endoscopic gastrojejunostomy tube: a pilot study. Gastrointest Endosc. 2013 Jul;78(1):154-7. doi: 10.1016/j.gie.2013.03.005. Epub 2013 Apr 24.'}]}, 'descriptionModule': {'briefSummary': "Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard PEGJ feeding tubes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive adult patients (18-80 years of age) with need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc).\n* Ability to give informed consent.\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)\n* Acute gastrointestinal bleeding\n* Coagulopathy defined by prothrombin time \\< 50% of control; PTT \\> 50 sec, or INR \\> 1.5), on chronic anticoagulation, or platelet count \\<50,000\n* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy\n* Cirrhosis with portal hypertension, varices, and/or ascites\n* Allergy to egg'}, 'identificationModule': {'nctId': 'NCT01892267', 'briefTitle': 'Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial', 'orgStudyIdInfo': {'id': 'NA_00079056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-propelled PEGJ feeding tube', 'description': 'Patients in this arm will receive self-propelled balloon PEGJ tube.', 'interventionNames': ['Device: PEG-J placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard PEGJ feeding tube', 'description': 'Patients in this arm will receive the standard commercially availabel PEGJ tube.', 'interventionNames': ['Device: PEG-J placement']}], 'interventions': [{'name': 'PEG-J placement', 'type': 'DEVICE', 'description': 'PEG-J placement', 'armGroupLabels': ['Self-propelled PEGJ feeding tube', 'Standard PEGJ feeding tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Mouen Khashab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Hospital Department of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine; Director of Therapeutic Endoscopy', 'investigatorFullName': 'Mouen Khashab', 'investigatorAffiliation': 'Johns Hopkins University'}}}}