Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus
Launched by JOHNS HOPKINS UNIVERSITY · Jun 30, 2020
Trial Information
Current as of April 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age 18 - 75 years
- • Known prior diagnosis of histologically-confirmed BE with or without dysplasia (as defined by the presence of specialized columnar epithelium anywhere in the tubular esophagus with \>= 1 cm of circumferential involvement or non-circumferential involvement of specialized columnar epithelium) \[Prague class \>1\] and history of initial complete eradication-IM following endoscopic ablation for Barrett's esophagus.
- • Documentation of complete ablation of BE by endoscopy and histology after radiofrequency or cryotherapy ablation on two endoscopic examinations at least 3 months apart, within most recent endoscopy performed within 6 months. Pathologic diagnosis determined by the expert pathologist at each site.
- • On PPI therapy, who opt for an intervention over lifelong drug dependence.
- • Hiatal hernia ≤ 2 cm or Hill grade \< 2 \[unless patients undergoing combined TIF and hiatal hernia repair\]
- • Abnormal esophageal acid exposure \[Percent esophageal acid exposure time \> 6% defined by Bravo ph monitoring (48 - 96 hours study)
- • Able to provide informed consent
- Exclusion Criteria:
- • Age \< 18 or \> 75 years
- • Inability to provide informed consent
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Saowanee Ngamruengphong
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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