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).

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NDO Full-thickness Plicator

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.

Primary outcomes

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

Secondary outcomes

GERD Medication Use

Time frame: 3 and 5-year
Improvement in overall health as measure by the short form Health Survey (SF-36).

Time frame: 3 and 5-year

Sponsors and collaborators

Lead sponsor

NDO Surgical, Inc.

Industry

Registry information

Acronym: LTFU

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Jan 7, 2008
Registry last updated: Jan 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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