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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

— LTFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587392
• Other study ID #: 135-01928
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: NDO Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
NDO Surgical, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. Epub 2006 Dec 16. — View 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. Epub 2007 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS).		3 and 5-years	No
Secondary	GERD Medication Use		3 and 5-year	No
Secondary	Improvement in overall health as measure by the short form Health Survey (SF-36).		3 and 5-year	No