Novel Endoluminal Clinical TreAtment of Reflux



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:22 - Any
Updated:2/17/2019
Start Date:November 1, 2017
End Date:December 2020
Contact:sharona segal-leibovich
Email:ssegal@impleomedical.com
Phone:6128453667

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A 12-month Double-blind, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Efficacy of Endoluminal Aluvra™ for the Treatment of Gastroesophageal Reflux Disease

This is a prospective, multi-center, double-blind, crossover, randomized controlled trial
designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.


Inclusion Criteria:

1. History of heartburn-like pain, regurgitation, or both prior to the initiation of
proton pump inhibitor (PPIs) therapy.

2. History of GERD symptoms of at least six months despite continuous PPIs.

3. GERD-HRQL score ≥15 after discontinuing PPI therapy.

4. GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point
improvement in heartburn subscore.

5. A minimum GERD-HRQL score while on PPIs of 2.

6. Pathologic acid exposure time, a baseline pH <4.0 for ≥ 5.3% of time during a 48-hour
evaluation period.

7. Twenty two years of age or older.

8. Life expectancy of at least two years.

9. Willing and able to return to the clinic or hospital for all evaluation procedures
scheduled throughout the course of this study.

10. Is capable of understanding clinical study procedures and giving informed consent.

Exclusion Criteria:

1. Unable to tolerate an endoscopic procedure

2. Presence of esophageal or gastric varices

3. Presence of erosive esophagitis (LA Classification of C or D)

4. Presence of a hiatal hernia > 2 cm

5. Presence of Barrett's esophagus

6. Presence of esophageal motility disorder

7. History of or known esophageal stricture or gross esophageal anatomic abnormalities

8. Symptoms of dysphagia more than once per week within the last six months

9. Obesity (BMI ≥ 35)

10. Gastric or esophageal cancer undergoing active treatment

11. Received radiation therapy to the esophagus and has fibrosis of the tissue at the
likely injection sites

12. Had an ablation procedure in the lower esophageal sphincter area

13. Has a condition that could lead to significant postoperative complications, including
current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder

14. Enrolled in a concurrent clinical trial

15. Inability to comply with study protocol due to a chronic disease, psychiatric illness,
alcoholism, drug abuse, or geographic distance (as determined by investigator)

16. Pregnant and/or given birth in the previous twelve months or who plan to become
pregnant in the next twelve months

17. Prior gastric or GERD surgery
We found this trial at
8
sites
Atlanta, Georgia 30309
Principal Investigator: Daniel Smith, MD
Phone: 404-445-7787
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Douglas Pleskow, MD
Phone: 617-677-4046
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: John Pandolfino, MD
Phone: 312-695-0330
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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401 West Hampden Place
Englewood, Colorado 80113
Principal Investigator: Reginald Bell, MD
Phone: 303-788-1636
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Los Angeles, California 90008
Principal Investigator: John Lipham, MD
Phone: 323-442-6252
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36500 Aurora Drive
Milwaukee, Wisconsin 53066
Principal Investigator: Nimish Vakil, MD
Phone: 414-649-7173
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Milwaukee, WI
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900 Blake Wilbur Drive
Palo Alto, California 94304
Principal Investigator: John Clarke, MD
Phone: 650-721-8437
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Palo Alto, CA
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Saint Louis, Missouri 63110
Principal Investigator: Prakash C Gyawali, MD
Phone: 314-362-3201
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Saint Louis, MO
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