Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT00586859
Status:
TERMINATED
Last Update Posted:
2008-05-30
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD
Sponsor:
NDO Surgical, Inc.
Organization:
Study Overview
Official Title:
Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsoring company ceased business operations.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: