CClinicalTrials.gg
Status unknownNCT01302301Updated Feb 28, 2011

Endolumenal Partial Myotomy for Esophageal Motility Disorders

A Phase 2 interventional study of Per oral endolumenal myotomy in Esophageal Motility Disorders, sponsored by The Oregon Clinic. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-02-28.

Sponsored by The Oregon Clinic · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from primary esophageal motility disorders.

Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately.

Results will be compared to historical data of conventional Heller myotomies.

02

Conditions studied

  • Esophageal Motility Disorders

Keywords

  • endolumenal myotomy, per oral endoscopic myotomy
03

In context

Esophageal Motility Disorders

43 studies on the registry are indexed under Esophageal Motility Disorders; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 28 across 24 interventional studies indexed under Esophageal Motility Disorders.

Browse Esophageal Motility Disorders studies →

Lead sponsor

The Oregon Clinic is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous mediastinal or esophageal surgery
  • Contraindications for EGD
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • ProcedurePer oral endolumenal myotomy

    flexible endoscopic submucosal esophageal partial myotomy

06

What researchers measure

Primary outcomes

  1. Esophageal Function Tests

    upper endoscopy, barium swallow, esophageal manometry,ph Test

    Time frame: 6 month

Secondary outcomes

  1. Quality of life score

    quality of life questionaire

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
    • Lee L Swanstrom, MD · Contact · lswanstrom@aol.com · 503-281-0561
    • Christy M Dunst, MD · Sub investigator
    • Erwin Rieder, MD · Sub investigator
    • Angi Gill, RN · Sub investigator
    Recruiting
08

References and documents

Publications

  • Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30. PubMed 20354937 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01302301
Lead sponsor
The Oregon Clinic
First posted
Feb 24, 2011
Start date
Jan 2011
Primary completion
Nov 2011 (estimated)
Last update
Feb 28, 2011

Study contacts

Lee L Swanstrom, MD
Contact
lswanstrom@aol.com
503 281 0561

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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