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Procedure
Short vs Standard Myotomy for Achalasia
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a shorter myotomy (4 cm) is just as effective as the standard myotomy (8 cm) for treating achalasia. The hypothesis is that the shorter myotomy will be just as effective, with shorter procedure times and fewer complications.
Who is the study for?
This trial is for adults over 18 with Type I or II achalasia, or those with EGJ Outflow Obstruction resembling achalasia. It's not for patients who've had previous POEM or Heller Myotomy treatments, pregnant individuals, prisoners, those with a life expectancy under a year due to other illnesses, severe coagulopathy or thrombocytopenia that can't be treated, and anyone too ill for elective endoscopy.Check my eligibility
What is being tested?
The study compares two surgical techniques in treating achalasia: a shorter (4 cm) myotomy versus the standard (8 cm) one during Per-Oral Endoscopic Myotomy (POEM). The goal is to see if the shorter procedure is just as effective based on patient-reported outcomes but has fewer complications and takes less time.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include complications from the endoscopic procedure such as infection, bleeding due to coagulopathy issues if present pre-operation, adverse reactions to anesthesia used during POEM surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare symptomatic improvement of achalasia based on Eckardt Score following POEM with 4 cm myotomy vs 8 cm myotomy
Secondary outcome measures
Compare post-POEM gastro-esophageal reflux between 4 cm myotomy and 8 cm myotomy using GERDQ assessment.
Compare procedural time and intra-procedural findings between 4 cm myotomy with POEM compared to 8 cm myotomy with POEM
Compare procedure complications after 4 cm myotomy with POEM compared to 8 cm myotomy with POEM
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Short Length MyotomyExperimental Treatment1 Intervention
Patients randomized to received 4 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia
Group II: Standard Length MyotomyPlacebo Group1 Intervention
Patients randomized to received 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for achalasia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Short Myotomy
2020
N/A
~60
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,171 Total Patients Enrolled
1 Trials studying Achalasia
400 Patients Enrolled for Achalasia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe swallowing disorder that needs surgery, as confirmed by a special test.My blood does not clot properly and cannot be corrected.My platelet count is below 50,000 and cannot be increased with treatment.A standard endoscope cannot be used on me.I cannot have an elective endoscopy due to my current health conditions.I have had POEM or Heller Myotomy surgery.I am 18 or older with a diagnosis of achalasia or similar swallowing disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Length Myotomy
- Group 2: Short Length Myotomy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being added to this research experiment?
"Per clinicaltrials.gov, this trial has ceased to search for additional participants - having been first posted on June 1st 2020 and last modified 11th March 2021. However, 17 other trials are still recruiting at the moment."
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