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

NCT ID: NCT00587392

Last Updated: 2008-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-09-30

Brief 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).

Conditions

Gastroesophageal Reflux Disease (GERD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Active NDO Endoscopic Full-thickness Plicator Procedure

NDO Full-thickness Plicator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NDO Surgical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

NDO Surgical

Principal Investigators

Douglas Pleskow, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center, Boston MA

Simon Lo, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Sinai Medical Center, Lost Angeles, CA

Richard Rothstein, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth Hitchcock Medical Center, Lebanon, NH

Christopher Gostout, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Rochester, MN

Robert Hawes, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Norman Marcon, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, Toronto, Ontario, Canada

Richard Kozarek, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center, Seattle, WA

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Virginia Mason Medical Center

Seattle, Washington, United States

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 17180259 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18027032 (View on PubMed)

Other Identifiers

135-01928

Identifier Type: -

Identifier Source: org_study_id