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Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD

NCT00586859 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2008-05-30

No results posted yet for this study

Summary

The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.

A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.

Conditions

  • GERD

Interventions

DEVICE

NDO Full-thickness Plicator

The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument. Additional sutures were placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. All plications were placed de novo, and re-treatment was not permitted.

Sponsors & Collaborators

  • NDO Surgical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00586859 on ClinicalTrials.gov