NCT02572193

Brief Summary

This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being performed to determine if patients can go home on the same day as their procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

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

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

2.2 years

First QC Date

October 6, 2015

Last Update Submit

December 15, 2016

Conditions

Esophageal Achalasia

Keywords

achalasiasurgery

Outcome Measures

Primary Outcomes (1)

  • percent of patients leaving on post-operative day 0

    1 year

Secondary Outcomes (1)

  • percent of patients who experience post-operative reflux

    1 year

Study Arms (1)

Active case

EXPERIMENTAL

POEM procedure

Procedure: POEM

Interventions

POEMPROCEDURE

To determine the feasibility of same-day discharge following a POEM procedure

Active case

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidate for a Heller myotomy
  • Their age is ≥18 years and ≤80 years
  • Able to give written consent

You may not qualify if:

  • Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
  • Previous Heller myotomy or POEM procedure
  • contra-indication to general anesthesia
  • Previous mediastinal surgery hiatal hernia greater than 2 cm
  • Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia \> 2cm.
  • Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Publications (5)

  • Shiwaku H, Inoue H, Sasaki T, Yamashita K, Ohmiya T, Takeno S, Nimura S, Yamashita Y. A prospective analysis of GERD after POEM on anterior myotomy. Surg Endosc. 2016 Jun;30(6):2496-504. doi: 10.1007/s00464-015-4507-0. Epub 2015 Sep 28.

    PMID: 26416381BACKGROUND

  • Barbieri LA, Hassan C, Rosati R, Romario UF, Correale L, Repici A. Systematic review and meta-analysis: Efficacy and safety of POEM for achalasia. United European Gastroenterol J. 2015 Aug;3(4):325-34. doi: 10.1177/2050640615581732.

    PMID: 26279840BACKGROUND

  • Inoue H, Sato H, Ikeda H, Onimaru M, Sato C, Minami H, Yokomichi H, Kobayashi Y, Grimes KL, Kudo SE. Per-Oral Endoscopic Myotomy: A Series of 500 Patients. J Am Coll Surg. 2015 Aug;221(2):256-64. doi: 10.1016/j.jamcollsurg.2015.03.057. Epub 2015 Apr 11.

    PMID: 26206634BACKGROUND

  • Stavropoulos SN, Modayil R, Friedel D. Per oral endoscopic myotomy for the treatment of achalasia. Curr Opin Gastroenterol. 2015 Sep;31(5):430-40. doi: 10.1097/MOG.0000000000000206.

    PMID: 26200001BACKGROUND

  • Patel K, Abbassi-Ghadi N, Markar S, Kumar S, Jethwa P, Zaninotto G. Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. 2016 Oct;29(7):807-819. doi: 10.1111/dote.12387. Epub 2015 Jul 14.

    PMID: 26175119BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Dennis Hong, MD

CONTACT

905-522-1155dennishong70@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

CA(1)