Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
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| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46202 |
| Conditions: |
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Gastroesophageal Reflux Disease - Heartburn - Regurgitation - Dyspepsia |
| Purpose: |
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The purpose of this study is to determine the safety and effectiveness of two separate
procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two
therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band
Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using
the Cook® Duette™ Multi-Band Mucosectomy device.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Subject is 18 years of age or older.
- Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy.
- Subject agrees to participate and signs consent form.
Exclusion Criteria:
- Patient is pregnant.
- Patient has a hiatal hernia greater than 2cm.
- Presence of persistent daily solid food dysphagia, unplanned weight loss over ten
pounds, esophageal bleeding, or vomiting more than once per week).
- Active medical condition that would preclude the subject from finishing this study.
- BMI > 39.
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| NCT ID: |
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NCT01199679 |
| Primary Contact: |
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Principal Investigator
Glen A. Lehman, MD
Indiana University Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Indianapolis, Indiana 46202
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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