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

GERD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00597792
• Other study ID #: 135-01762
• Status: Terminated
• Phase: N/A
• First received: January 9, 2008
• Last updated: May 29, 2008
• Start date: August 2004
• Est. completion date: November 2007

Study information

• Verified date: May 2008
• Source: NDO Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 131
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• GERD

Intervention

Device:
• NDO Full-thickness Plicator
A low-profile (=6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.

Locations

Country	Name	City	State
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Digestive Associates of Houston	Houston	Texas
United States	Northside Gastroenterology, Inc.	Indianapolis	Indiana
United States	Medical Center of Central Georgia	Macon	Georgia
United States	Nashville Medical Research and the Maria Nathanson Center of Excellence	Nashville	Tennessee
United States	Lenox Hill Hospital	New York	New York
United States	Stony brook University Medical Center	Stony brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
NDO Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		6, 12, 24, 36, 48, 60 months post-treatment	No
Secondary	GERD Medication Use		6, 12, 24, 36, 48, 60 months post-treatment	No
Secondary	Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)		6, 12, 24, 36, 48, 60 months post-procedure	No
Secondary	Subject satisfaction		6, 12, 24, 36, 48, 60 months post-treatment	No