Registry Study of the NDO Surgical Plicator for the Treatment of GERD
This study has been terminated.
(Sponsoring company ceased business operations)
Sponsor:
NDO Surgical, Inc.
Information provided by:
NDO Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00597792
First received: January 9, 2008
Last updated: May 29, 2008
Last verified: May 2008
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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
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 June 17, 2013