Clinical trial NCT00587392: Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results
Official title: Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal Reflux Disease (GERD)
Long-term follow-up (LTFU)
Endoscopic Full-thickness Plication
Plicator
Lead sponsor: NDO Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Boston MA
name: Douglas Pleskow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars Sinai Medical Center, Lost Angeles, CA
name: Simon Lo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth Hitchcock Medical Center, Lebanon, NH
name: Richard Rothstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic, Rochester, MN
name: Christopher Gostout, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Robert Hawes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital, Toronto, Ontario, Canada
name: Norman Marcon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Mason Medical Center, Seattle, WA
name: Richard Kozarek, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.