NCT00586859

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: NDO Surgical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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 The gastric wall was retracted into the Plicator instrument arms.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.

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2008-01-07
• Last updated: 2008-05-30

Locations

4 sites across 1 country: Germany