Registry Study of the NDO Surgical Plicator for the Treatment of GERD
NCT ID: NCT00597792
Last Updated: 2008-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
131 participants
INTERVENTIONAL
2004-08-31
2007-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Active Plicator Treatment
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.
Interventions
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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 Criteria
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Inclusion Criteria
* Subject agrees to study participation and signs/dates an informed consent form.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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NDO Surgical, Inc.
INDUSTRY
Responsible Party
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NDO Surgical, Inc.
Locations
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Medical Center of Central Georgia
Macon, Georgia, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Northside Gastroenterology, Inc.
Indianapolis, Indiana, United States
Lenox Hill Hospital
New York, New York, United States
Stony brook University Medical Center
Stony Brook, New York, United States
Nashville Medical Research and the Maria Nathanson Center of Excellence
Nashville, Tennessee, United States
Digestive Associates of Houston
Houston, Texas, United States
Countries
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Other Identifiers
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135-01762
Identifier Type: -
Identifier Source: org_study_id