PREcision MEDicine In Achalasia (PREMEDIA)

Conditions

• EGJ Outflow Obstruction Without Spastic/Hypercontractile Features
• Type I Achalasia
• Type II Achalasia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard Myotomy — PROCEDURE
  Myotomy during POEM of 8-10 cm in length, extending 2-3 cm into the gastric cardia; intention to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.
• Tailored Short Myotomy — PROCEDURE
  Myotomy during POEM of 4-5 cm in length, extending 1-2 cm into the gastric cardia; intend to perform selective circular myotomy, but allowing full thickness myotomy. FLIP is used to confirm adequate myotomy.

Study Details

The goal of this clinical trial is to learn if shorter Per-Oral Endoscopic Myotomy (POEM) works as well as a longer POEM in patients with trouble swallowing due to certain conditions. The main question\[s\] it aims to answer \[is/are\]: * Does making a smaller cut in the muscle at the bottom of the esophagus work just as well as making the standard bigger cut in relieving symptoms? * Does making the smaller cut reduce the side effects of the procedure compared to the standard bigger cut? Researchers will compare the symptoms and side effects of making a shorter cut to the symptoms and side effects of a longer cut. Participants will allow researchers to access their standard of care information in their medical record, complete questionnaires at up to 6 times over a 2-year period.

Key Dates

First listed

Dec 19, 2025

Start date

Apr 29, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2031

Completion

Aug 1, 2032

Study Design

Enrollment

372 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard Myotomy
• Experimental: Tailored Short Myotomy

Primary Outcome Measure

Clinical Response-Overall [ Time Frame: From enrollment to Year 2 ]

Central Contacts

• Elizabeth Yan, BS
  312-908-1723
  [email protected]
• Yasmin Pina, BS
  312-503-6459
  [email protected]

Locations (16)

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