Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results (LTFU)

This study has been completed.
Sponsor:
Information provided by:
NDO Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00587392
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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).


Condition Intervention
Gastroesophageal Reflux Disease (GERD)
Device: NDO Full-thickness Plicator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results

Resource links provided by NLM:


Further study details as provided by NDO Surgical, Inc.:

Primary Outcome Measures:
  • Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS). [ Time Frame: 3 and 5-years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GERD Medication Use [ Time Frame: 3 and 5-year ] [ Designated as safety issue: No ]
  • Improvement in overall health as measure by the short form Health Survey (SF-36). [ Time Frame: 3 and 5-year ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: December 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Active NDO Endoscopic Full-thickness Plicator Procedure
Device: NDO Full-thickness Plicator
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria (required prior to original treatment):

  • History of heartburn or regurgitation for at least 6-months requiring maintenance daily anti-secretory therapy;
  • esophageal manometry study demonstrating peristaltic amplitude >35mmHg and LES resting pressure >/=5mmHg;
  • Increased esophageal acid exposure demonstrated through a 24-hour pH study.

Exclusion Criteria (required prior to original treatment):

  • Erosive esophagitis (Savary-Miller grade III or IV);
  • Barrett's esophagus;
  • Esophageal stricture;
  • Hiatal hernia >2cm;
  • Persistent dysphagia, weight loss, esophageal bleeding, vomiting or gas-bloat
  • Esophageal or gastric varices;
  • Use of anticoagulants other than for cardiac prophylaxis
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587392

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M4X1W4
Sponsors and Collaborators
NDO Surgical, Inc.
Investigators
Principal Investigator: Douglas Pleskow, MD Beth Israel Deaconess Medical Center, Boston, MA
Principal Investigator: Simon Lo, MD Cedars Sinai Medical Center, Lost Angeles, CA
Principal Investigator: Richard Rothstein, MD Dartmouth Hitchcock Medical Center, Lebanon, NH
Principal Investigator: Christopher Gostout, MD Mayo Clinic, Rochester, MN
Principal Investigator: Robert Hawes, MD Medical University of South Carolina
Principal Investigator: Norman Marcon, MD St. Michael's Hospital, Toronto, Ontario, Canada
Principal Investigator: Richard Kozarek, MD Virginia Mason Medical Center, Seattle, WA
  More Information

Additional Information:
Publications:
Responsible Party: Bruce Gaumond, Associate Director, Clinical Affairs, NDO Surgical
ClinicalTrials.gov Identifier: NCT00587392     History of Changes
Other Study ID Numbers: 135-01928
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by NDO Surgical, Inc.:
Gastroesophageal Reflux Disease (GERD)
Long-term follow-up (LTFU)
Endoscopic Full-thickness Plication
Plicator

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014