Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT02572193

Conditions

Esophageal Achalasia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

POEM

Study Details

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.

Conditions

Esophageal Achalasia

Study ID

NCT02572193

Start date

Oct, 2015

Status verified date

Dec, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants must meet ALL of the following inclusion criteria:

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

Exclusion Criteria:

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)

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active case

POEM procedure

Interventions

POEM

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

Primary outcome measure

  • percent of patients leaving on post-operative day 0 [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Dennis Hong, MD

905-522-1155dennishong70@gmail.com

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Principal Investigator:

Dennis Hong, MD

More Information

Sponsor

McMaster University

Last update posted

Dec 16, 2016

Last verified

Dec, 2016

Keywords

  • achalasia
  • surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2016-12-16.