Registry Study of the NDO Surgical Plicator for the Treatment of GERD

Not Applicable

Terminated

• Conditions: GERD
• Interventions: Device: NDO Full-thickness Plicator

• Registration Number: NCT00597792
• Lead Sponsor: NDO Surgical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-29
• Last Update Posted: 2008-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	NDO Full-thickness Plicator	Active Plicator Treatment

Primary Outcome Measures

Name	Time	Method
Quality of Life	6, 12, 24, 36, 48, 60 months post-treatment

Secondary Outcome Measures

Name	Time	Method
GERD Medication Use	6, 12, 24, 36, 48, 60 months post-treatment
Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)	6, 12, 24, 36, 48, 60 months post-procedure
Subject satisfaction	6, 12, 24, 36, 48, 60 months post-treatment

Trial Locations

Locations (7)

Digestive Associates of Houston; 🇺🇸 Houston, Texas, United States

Evanston Northwestern Healthcare; 🇺🇸 Evanston, Illinois, United States

Stony brook University Medical Center; 🇺🇸 Stony brook, New York, United States

Northside Gastroenterology, Inc.; 🇺🇸 Indianapolis, Indiana, United States

Medical Center of Central Georgia; 🇺🇸 Macon, Georgia, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Nashville Medical Research and the Maria Nathanson Center of Excellence; 🇺🇸 Nashville, Tennessee, United States