Trials / Withdrawn
WithdrawnNCT04052581
Prospective Collection of Outcome Data Post POEM-TIF Procedure
Assessment of Safety and Outcomes in Patients Undergoing a Standard-of-care Combined POEM-TIF Procedure
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Johns Hopkins University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Recently, combined POEM-TIF has been performed successfully as a standard of care treatment for patients with severe GER after POEM. We aim to study the safety and feasibility of performing POEM-TIF (POEM and TIF in the same endoscopic session). This study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the POEM-TIF procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | POEM-TIF | Transoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2023-07-26
- Completion
- 2023-07-26
- First posted
- 2019-08-12
- Last updated
- 2023-07-28
Source: ClinicalTrials.gov record NCT04052581. Inclusion in this directory is not an endorsement.