Status:
COMPLETED
RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Reflux
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
16+ years
Brief Summary
The purpose of the prospective study is to collect information surrounding lung transplant in order to develop a randomized study to determine if prevention of gastroesophageal reflux disease (GERD) r...
Detailed Description
Prospective Group: Approximately 125 Bronchoalveolar Lavage (BAL) samples will be collected from eligible subjects at the time of clinical bronchoscopies and will be within 2 weeks of their esophageal...
Eligibility Criteria
Inclusion
- Male or non-pregnant female subject
- 16 years of age
- Recipient of a double-lung transplant
- Previously have a 24-hour esophageal pH and/or impedance probe study within 12 months prior to transplant and/or within 12 months following transplantation. If the subject expired prior to 12 months from transplant date, they must have had a 24-hour esophageal pH and/or impedance probe study to be eligible in the study.
Exclusion
- Recipient of a single-lung transplant
- Recipient of a re-do lung transplant
- Recipient of a double-lung/heart or double-lung/ other organ transplant
- Do not have a 24-hour esophageal pH and/or impedance probe study within 12 months pre-transplant or within 12 months following transplantation. The subject expired less than 12 months post transplant without having a 24-hour esophageal pH and/or impedance probe study
- No Spirometry data is available for the subject
- Subject who is participating in any other interventional clinical study
- Unable to provide written informed consent or participate in long-term follow-up
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
647 Patients enrolled
Trial Details
Trial ID
NCT01406210
Start Date
September 1 2011
End Date
August 1 2013
Last Update
September 12 2014
Active Locations (4)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
University of Toronto
Toronto, Ontario, Canada, M5G2C4