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

This study has been terminated.
(Sponsoring company ceased business operations)
Sponsor:
Information provided by:
NDO Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00597792
First received: January 9, 2008
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
GERD
Device: NDO Full-thickness Plicator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Registry Study of the NDO Surgical Plicator for the Treatment of GERD

Resource links provided by NLM:


Further study details as provided by NDO Surgical, Inc.:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GERD Medication Use [ Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment ] [ Designated as safety issue: No ]
  • Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs) [ Time Frame: 6, 12, 24, 36, 48, 60 months post-procedure ] [ Designated as safety issue: No ]
  • Subject satisfaction [ Time Frame: 6, 12, 24, 36, 48, 60 months post-treatment ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: August 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Active Plicator Treatment
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597792

Locations
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
United States, Indiana
Northside Gastroenterology, Inc.
Indianapolis, Indiana, United States, 46260
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10021
Stony brook University Medical Center
Stony brook, New York, United States, 11794
United States, Tennessee
Nashville Medical Research and the Maria Nathanson Center of Excellence
Nashville, Tennessee, United States, 37205
United States, Texas
Digestive Associates of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
NDO Surgical, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Bruce Gaumond/Associate Director, Clinical Affairs, NDO Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00597792     History of Changes
Other Study ID Numbers: 135-01762
Study First Received: January 9, 2008
Last Updated: May 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NDO Surgical, Inc.:
Gastroesophageal Reflux Disease (GERD)
Plicator
Full-thickness Plication

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 09, 2014