Recruiting

Observational StudyPREcision MEDicine In Achalasia (PREMEDIA) - Cohort

Sponsor:

Northwestern University

Code:

NCT07293689

Conditions

Type III Achalasia

EGJ Outflow Obstruction With Spastic/Hypercontractile Features

Jackhammer Esophagus

Distal Esophageal Spasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty swallowing due to certain conditions. The main question it aims to answer is: does pre-POEM testing help the physician choose how long to cut the muscle.

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 III Achalasia

EGJ Outflow Obstruction With Spastic/Hypercontractile Features

Jackhammer Esophagus

Distal Esophageal Spasm

Study ID

NCT07293689

Start date

Dec 1, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2032

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18
2. Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
3. Eckardt Score > 3

Exclusion Criteria:

Exclusion:

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

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 California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Alexander Gonsalves, Lead Study Coordinator

858-246-5236 PREMEDIA@health.ucsd.edu

Principal Investigator:

Rena Yadlapati, MD

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

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Darren Nix, Lead Study Coordinator

314-273-1432 Premediasurgerytrial@wustl.edu

Principal Investigator:

Chandra Gyawali, 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

Oct 13, 2026

Last verified

Oct, 2026

Keywords

achalasia
EGJOO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.