Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by The Oregon Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT01302288
First received: February 23, 2011
Last updated: February 25, 2011
Last verified: October 2010
History of Changes
  Purpose

Achalasia is a primary esophageal motility disorder 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.


Condition Intervention Phase
Achalasia
 Procedure: Per oral endolumenal myotomy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by The Oregon Clinic:

Primary Outcome Measures:
  • Esophageal function testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    esophageal manometry test, pH test, upper endoscopy,barium swallow


Secondary Outcome Measures:
  • Quality of life score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    quality of life questionaire
Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Per oral endolumenal myotomy
    patient cohort having flexible endoscopic submucosal esophageal partial myotomy
Detailed Description:

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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302288

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

Locations
United States, Oregon
Good Samaritan Hospital, Legacy Health System Recruiting
Portland, Oregon, United States, 97210
Contact: Lee L Swanstrom, MD    503-281-0561    lswanstrom@aol.com   
Sub-Investigator: Christy M Dunst, MD         
Sub-Investigator: Erwin Rieder, MD         
Sub-Investigator: Angi Gill, RN         
Sponsors and Collaborators
The Oregon Clinic
  More Information

Publications:

Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01302288     History of Changes
Other Study ID Numbers: LEG1056
Study First Received: February 23, 2011
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Oregon Clinic:
endolumenal myotomy, per oral endoscopic myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Deglutition Disorders
Digestive System Diseases
 Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on March 01, 2015