Registry Study of the NDO Surgical Plicator for the Treatment of GERD
Primary Purpose
GERD
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NDO Full-thickness Plicator
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring Gastroesophageal Reflux Disease (GERD), Plicator, Full-thickness Plication
Eligibility 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.
Sites / Locations
- Medical Center of Central Georgia
- Evanston Northwestern Healthcare
- Northside Gastroenterology, Inc.
- Lenox Hill Hospital
- Stony brook University Medical Center
- Nashville Medical Research and the Maria Nathanson Center of Excellence
- Digestive Associates of Houston
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
A
Arm Description
Active Plicator Treatment
Outcomes
Primary Outcome Measures
Quality of Life
Secondary Outcome Measures
GERD Medication Use
Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)
Subject satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00597792
Brief Title
Registry Study of the NDO Surgical Plicator for the Treatment of GERD
Official Title
Registry Study of the NDO Surgical Plicator for the Treatment of GERD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Sponsoring company ceased business operations
Study Start Date
August 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NDO Surgical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
Gastroesophageal Reflux Disease (GERD), Plicator, Full-thickness Plication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Active Plicator Treatment
Intervention Type
Device
Intervention Name(s)
NDO Full-thickness Plicator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
6, 12, 24, 36, 48, 60 months post-treatment
Secondary Outcome Measure Information:
Title
GERD Medication Use
Time Frame
6, 12, 24, 36, 48, 60 months post-treatment
Title
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
Title
Subject satisfaction
Time Frame
6, 12, 24, 36, 48, 60 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Northside Gastroenterology, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Stony brook University Medical Center
City
Stony brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Nashville Medical Research and the Maria Nathanson Center of Excellence
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Digestive Associates of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Registry Study of the NDO Surgical Plicator for the Treatment of GERD
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