Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-03 @ 9:15 AM
Study NCT ID:
NCT03123835
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-05
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Analysis of POEM and Endoluminal Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}, {'id': 'D005747', 'term': 'Gastric Fistula'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C432915', 'term': 'nephronectin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in GERDDQ', 'timeFrame': '3-6 months', 'description': 'Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)'}], 'secondaryOutcomes': [{'measure': 'Decrease in Eckardt scoring', 'timeFrame': '30 days', 'description': 'Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Achalasia', 'Fistula', 'Obesity', 'POEM', 'GERD', 'endoscopic', 'treatments', 'post bariatric surger weight gain', 'endoluminal', 'Bariatric Surgery', 'Barretts'], 'conditions': ['Achalasia', 'Gastric Fistula', 'Weight Gain After Primary Weight Loss Surgery', 'Marginal Ulcer', 'Stenoses', 'Gastric Nec']}, 'descriptionModule': {'briefSummary': 'Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.', 'detailedDescription': 'Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male and female patients 18-80 years of age\n* Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)\n* Gastrointestinal Reflux Disease\n* Achalasia\n* Barrett's Esophagus\n* Post Bariatric Surgery conditions\n* Other gastrointestinal and postsurgical disorders.\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees."}, 'identificationModule': {'nctId': 'NCT03123835', 'briefTitle': 'Outcome Analysis of POEM and Endoluminal Therapies', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms', 'orgStudyIdInfo': {'id': '676956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'Patients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples.', 'interventionNames': ['Procedure: Endoscopic Intervention']}], 'interventions': [{'name': 'Endoscopic Intervention', 'type': 'PROCEDURE', 'otherNames': ['Endoluminal Therapies, POEM, Endoscopic Revision'], 'description': 'After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Univesity of California Davis Health System', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Mohamed R Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U.C. Davis Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'de-identified data will be maintained until study closure. Statistical summary of data will be published with any journal articles submitted for review/approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}