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

December 21, 2007
December 21, 2007
December 2004
September 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results
Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Gastroesophageal Reflux Disease (GERD)
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.
A
Active NDO Endoscopic Full-thickness Plicator Procedure
Intervention: Device: NDO Full-thickness Plicator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00587392
135-01928
No
Bruce Gaumond, Associate Director, Clinical Affairs, NDO Surgical
NDO Surgical, Inc.
Not Provided
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
NDO Surgical, Inc.
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP