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Observational Study of TIF for Barrett's Esophagus After Ablation

This observational study is looking at the outcomes of a procedure called Transoral Incisionless Fundoplication (TIF) in people who have had successful endoscopic ablation for Barrett's esophagus (a precancerous condition where the lining of the esophagus changes). TIF is a procedure that creates a new valve at the top of the stomach to help prevent acid reflux. Researchers want to see if TIF can help prevent Barrett's esophagus from returning. You may be able to join if you are between 18 and 75 years old and have a known diagnosis of Barrett's esophagus. The main goal is to see what percentage of participants have normal acid exposure in their esophagus after 6 months. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 50 participants. It is not a randomized or blinded study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months to measure esophageal acid exposure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04457193

Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus

Enrolling by Invitation
Not specifiedAges 18–75Observational
Johns Hopkins University
~50 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:TIF

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with normal esophageal acid exposure time
Measured over 6 months

Conditions

Barrett Esophagus
Transoral Incisionless Fundoplication

Explore related trials

Barrett Esophagus

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Saowanee Ngamruengphong · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Age \< 18 or \> 75 years
Inability to provide informed consent

What this trial measures

  • Percentage of participants with normal esophageal acid exposure time6 months

    Normal esophageal acid exposure time is 6 percent or less.