NCT01302301

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

February 28, 2011

Status Verified

November 1, 2010

Enrollment Period

10 months

First QC Date

February 23, 2011

Last Update Submit

February 25, 2011

Conditions

Esophageal Motility Disorders

Keywords

endolumenal myotomy, per oral endoscopic myotomy

Outcome Measures

Primary Outcomes (1)

  • Esophageal Function Tests

    upper endoscopy, barium swallow, esophageal manometry,ph Test

    6 month

Secondary Outcomes (1)

  • Quality of life score

    6 months

Interventions

Per oral endolumenal myotomyPROCEDURE

flexible endoscopic submucosal esophageal partial myotomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous mediastinal or esophageal surgery
  • Contraindications for EGD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20354937BACKGROUND

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Lee L Swanstrom, MD

CONTACT

503 281 0561lswanstrom@aol.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 24, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Last Updated

February 28, 2011

Record last verified: 2010-11

Locations

US(1)