NCT01873300

Brief Summary

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2012

Typical duration for phase_1

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

February 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

2.5 years

First QC Date

June 5, 2013

Last Update Submit

April 8, 2015

Conditions

Achalasia

Keywords

AchalasiaDysphagiaEndoscopicMyotomyHellerNOTESPOEM

Outcome Measures

Primary Outcomes (1)

  • Improvement of quality of life and dysphagia symptoms

    Patients will be given a quality of life and dysphagia questionare before surgery and at 3 and 6 months after surgery

    6 months

Study Arms (1)

treatment group

EXPERIMENTAL

Patients undergoing POEM procedure

Procedure: Endoscopic Esophageal Myotomy

Interventions

Endoscopic Esophageal MyotomyPROCEDURE

Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.

Also known as: POEM, Trans-esophageal endoscopic myotomy, Per-oral endoscopic myotomy, Endoscopic Heller Myotomy
treatment group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of achalasia
  • Age 18-65
  • ASA class 1-2

You may not qualify if:

  • Pregnant women
  • Any prior surgical or endoscopic treatment for achalasia except dilation less than 20 mm
  • Patients who are taking immunosuppressive medications or are immunocompromised Patients on blood thinners or aspirin or with history of bleeding disorders
  • ASA class III patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masschusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Inoue H, Kudo SE. [Per-oral endoscopic myotomy (POEM) for 43 consecutive cases of esophageal achalasia]. Nihon Rinsho. 2010 Sep;68(9):1749-52. Japanese.

    PMID: 20845759BACKGROUND

  • Inoue H, Tianle KM, Ikeda H, Hosoya T, Onimaru M, Yoshida A, Minami H, Kudo SE. Peroral endoscopic myotomy for esophageal achalasia: technique, indication, and outcomes. Thorac Surg Clin. 2011 Nov;21(4):519-25. doi: 10.1016/j.thorsurg.2011.08.005.

    PMID: 22040634BACKGROUND

  • von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.

    PMID: 22068665BACKGROUND

MeSH Terms

Conditions

Esophageal AchalasiaDeglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • David W Rattner, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Ozanan R Meireles, MD

    Masschusetts General Hospital / Harvard Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery - Harvard Medical School

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 10, 2013

Study Start

February 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

US(1)