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Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia (POEM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by The Oregon Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lee Swanstrom, The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT01399476
First received: July 19, 2011
Last updated: April 12, 2012
Last verified: April 2012

July 19, 2011
April 12, 2012
September 2010
September 2012   (final data collection date for primary outcome measure)
Improved quality of life as defined by survey pre and post surgery [ Time Frame: six months ] [ Designated as safety issue: No ]
patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
Same as current
Complete list of historical versions of study NCT01399476 on ClinicalTrials.gov Archive Site
  • Negative pH test [ Time Frame: six months ] [ Designated as safety issue: No ]
    Patients will be required to have 24 hour pH testing after surgery.
  • Bleeding [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    recorded blood loss will be taken during surgery.
Same as current
Not Provided
Not Provided
 
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia
Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia

This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.

By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Achalasia
  • Procedure: Endoscopic Myotomy
    Patients will receive the surgical procedure described in the summary (POEM).
    Other Name: POEM
  • Procedure: Endoscopic Myotomy for treatment of achalasia
    Surgical procedure
    Other Name: POEM
Experimental: Endoscopic Myotomy
Interventions:
  • Procedure: Endoscopic Myotomy
  • Procedure: Endoscopic Myotomy for treatment of achalasia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2013
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to undergo general anesthesia
  • Age > 18 yrs. of age and < 85 yrs. of age
  • Ability to give informed consent
  • Candidate for elective Heller myotomy

Exclusion Criteria:

  • Previous mediastinal or esophageal surgery
  • Contraindications for esophagogastroduodenoscopy
  • BMI > 45
Both
18 Years to 85 Years
No
Contact: Angi B Gill, RN 503-281-0561 agill@orclinic.com
United States
 
NCT01399476
1056
No
Lee Swanstrom, The Oregon Clinic
The Oregon Clinic
Not Provided
Principal Investigator: Lee L Swanstrom, MD The Oregon Clinic
The Oregon Clinic
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP