Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-26 @ 6:19 AM
Study NCT ID:
NCT00587392
Status:
COMPLETED
Last Update Posted:
2008-01-07
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-21', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS).', 'timeFrame': '3 and 5-years'}], 'secondaryOutcomes': [{'measure': 'GERD Medication Use', 'timeFrame': '3 and 5-year'}, {'measure': 'Improvement in overall health as measure by the short form Health Survey (SF-36).', 'timeFrame': '3 and 5-year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux Disease (GERD)', 'Long-term follow-up (LTFU)', 'Endoscopic Full-thickness Plication', 'Plicator'], 'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'referencesModule': {'references': [{'pmid': '17180259', 'type': 'RESULT', 'citation': 'Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc. 2007 Mar;21(3):439-44. doi: 10.1007/s00464-006-9121-8. Epub 2006 Dec 16.'}, {'pmid': '18027032', 'type': 'RESULT', 'citation': 'Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lo S, Hawes R, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results. Surg Endosc. 2008 Feb;22(2):326-32. doi: 10.1007/s00464-007-9667-0. Epub 2007 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to gather long-term follow-up data on patients treated with the Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at seven U.S. sites. A subset of those patients were subsequently reassessed via symptom questionnaires in this long-term (60-month) follow-up analysis. The initial open-label study was completed and officially closed at the completion of 1-year follow-up. This current study was designed to collect long-term follow-up data on previously plicated subjects all of whom were recruited de novo from the original study population. Study endpoints were prospectively defined. The primary study objectives were to assess: reduction in GERD symptoms through analysis of the GERD Health Related Quality of Life (HRQL) questionnaire and the Gastrointestinal Symptom Rating Scale (GSRS); reduction in use of GERD medications, and change in overall physical and psychological health as measured by the Short Form Health Survey (SF-36).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients previously treated with the NDO Full-thickness Plicator in the original open-label study and who met the long-term Follow-up (LTFU) protocol inclusion and exclusion crieria were eligible for study participation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (required prior to original treatment):\n\n* History of heartburn or regurgitation for at least 6-months requiring maintenance daily anti-secretory therapy;\n* esophageal manometry study demonstrating peristaltic amplitude \\>35mmHg and LES resting pressure \\>/=5mmHg;\n* Increased esophageal acid exposure demonstrated through a 24-hour pH study.\n\nExclusion Criteria (required prior to original treatment):\n\n* Erosive esophagitis (Savary-Miller grade III or IV);\n* Barrett's esophagus;\n* Esophageal stricture;\n* Hiatal hernia \\>2cm;\n* Persistent dysphagia, weight loss, esophageal bleeding, vomiting or gas-bloat\n* Esophageal or gastric varices;\n* Use of anticoagulants other than for cardiac prophylaxis\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT00587392', 'acronym': 'LTFU', 'briefTitle': 'Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results', 'organization': {'class': 'INDUSTRY', 'fullName': 'NDO Surgical, Inc.'}, 'officialTitle': 'Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results', 'orgStudyIdInfo': {'id': '135-01928'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Active NDO Endoscopic Full-thickness Plicator Procedure', 'interventionNames': ['Device: NDO Full-thickness Plicator']}], 'interventions': [{'name': 'NDO Full-thickness Plicator', 'type': 'DEVICE', 'description': 'The NDO Full-thickness Plicator intervention was performed as part of the original open-label Plicator study as previously reported. This intervention did not take place as part of this long-term follow-up data collection study.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M4X1W4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Douglas Pleskow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center, Boston MA'}, {'name': 'Simon Lo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars Sinai Medical Center, Lost Angeles, CA'}, {'name': 'Richard Rothstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth Hitchcock Medical Center, Lebanon, NH'}, {'name': 'Christopher Gostout, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic, Rochester, MN'}, {'name': 'Robert Hawes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Norman Marcon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Michael's Hospital, Toronto, Ontario, Canada"}, {'name': 'Richard Kozarek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Mason Medical Center, Seattle, WA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NDO Surgical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Bruce Gaumond, Associate Director, Clinical Affairs', 'oldOrganization': 'NDO Surgical'}}}}