Recruiting

Phase 3

POEM ComparisonPREcision MEDicine In Achalasia (PREMEDIA)

Sponsor:

Northwestern University

Code:

NCT07293650

Conditions

Type I Achalasia

Type II Achalasia

EGJ Outflow Obstruction Without Spastic/Hypercontractile Features

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Myotomy

Tailored Short Myotomy

Study Details

Brief summary:

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.

Conditions

Type I Achalasia

Type II Achalasia

EGJ Outflow Obstruction Without Spastic/Hypercontractile Features

Study ID

NCT07293650

Start date

Apr 29, 2026

Status verified date

Aug, 2026

Completion date

Aug 1, 2032

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Age ≥ 18
2. Type I achalasia or type II achalasia or cEGJOO
3. Eckardt score > 3

Exclusion Criteria

The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study:

1. Prior POEM
2. Prior surgical treatment for achalasia
3. Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months
4. Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy
5. Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication
6. Known secondary achalasia related to malignancy (pseudoachalasia)
7. Known eosinophilic esophagitis
8. Diverticulum (> 2 cm) in distal esophagus
9. Megaesophagus
10. Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic)
11. Pregnancy
12. Standard contraindications to general anesthesia
13. Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices)
14. Unwillingness or inability to consent for the study
15. Anticipated inability to follow protocol
16. Weekly (or more frequent) opioid medication use in the last 2 years

Study Design

Enrollment

372 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Myotomy

experimental: Tailored Short Myotomy

Interventions

Standard Myotomy

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

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.

Primary outcome measure

Clinical Response-Overall [ Time Frame: From enrollment to Year 2 ]
Clinical Response-by Sex [ Time Frame: From enrollment to Year 2 ]
Clinical Response-by Race [ Time Frame: From Enrollment to Year 2 ]
Clinical Response-by Ethnicity [ Time Frame: From Enrollment to Year 2 ]

Central Contacts and Locations

Central contacts

Elizabeth Yan, BS

312-908-1723 premedia.dcc@northwestern.edu

Yasmin Pina, BS

312-503-6459 premedia.dcc@northwestern.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

April Goddard, Lead Study Coordinator, PA-C

352-273-9483 DOM-GIResereachTeam@ad.ufl.edu

Principal Investigator:

Peter Draganov, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Halley Fowler, Lead Study Coordinator

404-778-3184 halley.fowler@emory.edu

Principal Investigator:

Anand Jain, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Eric Pfannkuche, Lead Study Coordinator

312-926-4525 PREMEDIA@northwestern.edu

Principal Investigator:

John Pandolfino, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Madison Paylor, Lead Study Coordinator

617-726-0196 premedia@mgb.org

Principal Investigator:

Kyle Staller, MD

Atrium Health/Wake Forest

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Greg Scarola, Lead Study Coordinator

(704) 355-2000 PREMEDIA@advocatehealth.org

Principal Investigator:

Badih Elmunzer, MD

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Stephanie Baker, Lead Study Coordinator

216-778-5736 premedia@metrohealth.org

Principal Investigator:

Ronnie Fass, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Larry Raber, Lead Study Coordinator

615-322-4643 larry.w.raber@vumc.org

Principal Investigator:

Dhyanesh Patel, MD

More Information

Sponsor

Northwestern University

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

achalasia
EGJOO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-28.