NCT01399476

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

8.9 years

First QC Date

July 19, 2011

Last Update Submit

August 29, 2019

Conditions

Achalasia

Keywords

Achalasia

Outcome Measures

Primary Outcomes (1)

  • Improved quality of life as defined by survey pre and post surgery

    patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.

    six months

Secondary Outcomes (2)

  • Negative pH test

    six months

  • Bleeding

    1 year

Study Arms (1)

Endoscopic Myotomy

EXPERIMENTAL
Procedure: Endoscopic MyotomyProcedure: Endoscopic Myotomy for treatment of achalasia

Interventions

Endoscopic MyotomyPROCEDURE

Patients will receive the surgical procedure described in the summary (POEM).

Also known as: POEM
Endoscopic Myotomy
Endoscopic Myotomy for treatment of achalasiaPROCEDURE

Surgical procedure

Also known as: POEM
Endoscopic Myotomy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Previous mediastinal or esophageal surgery
  • Contraindications for esophagogastroduodenoscopy
  • BMI \> 45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Oregon Clinic

Portland, Oregon, 97210, United States

Location

Related Publications (1)

  • Kurian AA, Dunst CM, Sharata A, Bhayani NH, Reavis KM, Swanstrom LL. Peroral endoscopic esophageal myotomy: defining the learning curve. Gastrointest Endosc. 2013 May;77(5):719-25. doi: 10.1016/j.gie.2012.12.006. Epub 2013 Feb 5.

    PMID: 23394838DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Lee L Swanstrom, MD

    The Oregon Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lee Swanstrom, MD

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

September 1, 2010

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

US(1)