Recruiting
Phase 2

Endolumenal Myotomy

Sponsor:

The Oregon Clinic

Code:

NCT01302301

Conditions

Esophageal Motility Disorders

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Per oral endolumenal myotomy

Study Details

Brief summary:

Achalasia and esophageal spasm are primary esophageal motility disorders where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to overcome the need for invasive surgery.

Conditions

Esophageal Motility Disorders

Study ID

NCT01302301

Start date

Jan, 2011

Status verified date

Nov, 2010

Primary completion date

Nov, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Candidate for elective Heller myotomy
  • Ability to undergo general anesthesia
  • Ability to give informed consent

Exclusion Criteria:

  • Previous mediastinal or esophageal surgery
  • Contraindications for EGD

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Per oral endolumenal myotomy

flexible endoscopic submucosal esophageal partial myotomy

Primary outcome measure

  • Esophageal Function Tests [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

Lee L Swanstrom, MD

503 281 0561lswanstrom@aol.com

Locations

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Lee L Swanstrom, MD

503-281-0561lswanstrom@aol.com

More Information

Sponsor

The Oregon Clinic

Last update posted

Feb 28, 2011

Last verified

Nov, 2010

Keywords

  • endolumenal myotomy, per oral endoscopic myotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Oregon Clinic on 2011-02-28.