Clinical trial NCT00597792: Registry Study of the NDO Surgical Plicator for the Treatment of GERD
Official title: Registry Study of the NDO Surgical Plicator for the Treatment of GERD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: GERD
Keywords: Gastroesophageal Reflux Disease (GERD)
Plicator
Full-thickness Plication
Lead sponsor: NDO Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed.

This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.


Eligibility criteria: Inclusion Criteria:

* Subject is suitable for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
* Subject agrees to study participation and signs/dates an informed consent form.

Exclusion Criteria:

* Significant esophageal dysmotility as determined by manometry
* Esophagitis grade III or IV (Savary-Miller)
* Barrett's epithelium
* Hiatus hernia \> 2cm
* Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
* Esophageal or gastric varices
* Previous endoscopic or surgical anti-reflux procedure
* Other esophageal or gastric surgery
* Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
* Pregnancy.

Primary outcomes:
measure: Quality of Life
timeFrame: 6, 12, 24, 36, 48, 60 months post-treatment
Secondary outcomes:
measure: GERD Medication Use
timeFrame: 6, 12, 24, 36, 48, 60 months post-treatment
measure: Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)
timeFrame: 6, 12, 24, 36, 48, 60 months post-procedure
measure: Subject satisfaction
timeFrame: 6, 12, 24, 36, 48, 60 months post-treatment
Other outcomes:
Locations:
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Indianapolis
country: United States
facility: Northside Gastroenterology, Inc.
state: Indiana
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Stony brook
country: United States
facility: Stony brook University Medical Center
state: New York
city: Nashville
country: United States
facility: Nashville Medical Research and the Maria Nathanson Center of Excellence
state: Tennessee
city: Houston
country: United States
facility: Digestive Associates of Houston
state: Texas
Study officials:
References: