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NCT06042127 · ClinicalTrials.gov registry record · NA
POEM-F for Achalasia International Study
A NA study of Achalasia, sponsored by Chinese University of Hong Kong.
- Recruiting
- Registry status
- NA
- Development phase
- 81
- Enrollment target
- 7
- Study locations
NCT06042127 is a NA study of Achalasia that is actively recruiting participants, run by Chinese University of Hong Kong. The registered enrollment target is 81 participants, below the 130-participant average among 7 other Achalasia trials with a reported enrollment target (38% lower). The trial reports 7 study locations across 2 states.
The verdict
NCT06042127, a NA study of Achalasia, is actively recruiting participants, sponsored by Chinese University of Hong Kong.
- RECRUITING
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
- 7
- Study locations
Study Summary
Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in up to 50-60% of patients. In order to reduce the risk of GERD, endoscopic fundoplication has been developed as a novel procedure mimicking surgical anterior partial fundoplication that can be performed in the same session as POEM (POEM-F). Case series of POEM-F in patients with achalasia reported encouraging outcomes of low GERD rate of \~12% at 1 year. Prospective comparative data between POEM-F and conventional POEM on post-procedure GERD is current lacking. The investigators therefore designed an international multicenter prospective randomized study to investigate the efficacy of POEM-F. The investigators postulate that POEM-F could reduce the incidence of post-procedure GERD when compared with conventional POEM. This is an international multicenter randomized controlled trial conducted between high volume expert centers from Hong Kong SAR, China, India and United States of America. Adult patients with manometry confirmed achalasia would be randomised to undergo POEM-F or POEM. The procedure would be performed by experts with vast experience in POEM. The primary outcome is the incidence of post-procedure GERD at 1 year, defined by the updated Lyon consensus. Secondary outcomes include technical and clinical success rates, adverse events, post-POEM endoscopic and manometry findings as well as patients' symptom scores. Sample size calculation Based on existing pilot comparative data on POEM-F and POEM, it is estimated that 84 patients would be required to demonstrate a difference in post-procedure GERD of 47.6% to 18.2%, with 80% power and false positive rate of 0.05, accounting for 10% loss to follow-up. Purpose and potential The current study proposal could demonstr
Conditions Studied
Interventions
- PROCEDURE POEM-F
- PROCEDURE Conventional POEM
Study Locations (7)
Other
- Nanfang Hospital, Southern Medical University - Guangzhou
- The Chinese University of Hong Kong - Hong Kong
- Post Graduate Institute of Medical Education and Research - Chandigarh
- Asian Institute of Gastroenterology - Hyderabad
- Baldota Institute of Digestive Sciences - Mumbai
- Deenanath Mangeshkar Hospital & Research Center - Pune
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06042127
The ClinicalTrials.gov registry entry for NCT06042127 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 7 other Achalasia trials with a reported enrollment target (38% lower). The listed sponsor is Chinese University of Hong Kong, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Achalasia appearing as the primary indexed condition, and to 2 interventions - of which POEM-F is the first listed.
NCT06042127 reports 7 study locations spanning 2 distinct geographic areas - top geographies include Other, Maryland.
Frequently Asked Questions
What is clinical trial NCT06042127 about?
NCT06042127 is a clinical study titled "POEM-F for Achalasia International Study". Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in u...
What is the current status of trial NCT06042127?
This trial is currently recruiting. It is a NA study. The enrollment target is 81 participants. The study started on 2023-12-01. Estimated completion is 2026-10-31.
What conditions does trial NCT06042127 study?
This clinical trial studies the following conditions: Achalasia.
What interventions are being tested in trial NCT06042127?
The interventions under investigation include: POEM-F (PROCEDURE), Conventional POEM (PROCEDURE).
Who is sponsoring clinical trial NCT06042127?
This trial is sponsored by Chinese University of Hong Kong, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06042127 being conducted?
This trial has 7 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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