Recruiting

Observational Study

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

Aug, 2026

Completion date

Aug 31, 2032

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

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

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

Yasmin Pina, BS

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

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

April Goddard, Lead Study Coordinator, PA-C

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

Principal Investigator:

Peter Draganov, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Halley Fowler, Lead Study Coordinator

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

Principal Investigator:

Anand Jain, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Eric Pfannkuche, Lead Study Coordinator

312-926-4525PREMEDIA@northwestern.edu

Principal Investigator:

John Pandolfino, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Madison Paylor, Lead Study Coordinator

617-726-0196premedia@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) 355-2000PREMEDIA@advocatehealth.org

Principal Investigator:

Badih Elmunzer, MD

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Stephanie Baker, Lead Study Coordinator

216-778-5736premedia@metrohealth.org

Principal Investigator:

Ronnie Fass, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Larry Raber, Lead Study Coordinator

615-322-4643larry.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.