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Neurotoxin

Botox and/or Esophageal Dilation for Achalasia

Phase 4
Waitlist Available
Led By Dhyanesh Patel, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial compared the effects of two treatments for achalasia, a condition that affects the esophagus.

Who is the study for?
This trial is for adults with achalasia, a rare disorder affecting esophagus movement, who can't have standard treatments like dilation or surgery. They must be undergoing routine upper endoscopy for their condition but cannot participate if they're under 18 or have had previous surgeries for reflux or peptic ulcers.Check my eligibility
What is being tested?
The study compares two approaches to ease symptoms of achalasia: one group receives Botox injections in the lower esophageal sphincter (LES), while the other gets both Botox and esophageal dilation using a balloon dilator during an endoscopy.See study design
What are the potential side effects?
Possible side effects include sore throat, infection risk at the injection site, difficulty swallowing, heartburn, chest pain, and in rare cases breathing difficulties due to botulinum toxin spreading from the area of injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have achalasia and cannot undergo surgery or other definitive treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
dysphagia score

Trial Design

2Treatment groups
Active Control
Group I: Botulinum toxinActive Control3 Interventions
A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation.
Group II: Botulinum toxin and dilationActive Control4 Interventions
A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation. Subjects will also undergo distal esophageal dilation using a 20mm through the scope balloon positioned across the LES.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,142 Total Patients Enrolled
2 Trials studying Achalasia
90 Patients Enrolled for Achalasia
Dhyanesh Patel, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
123 Total Patients Enrolled

Media Library

Botulinum toxin type A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT03654066 — Phase 4
Achalasia Research Study Groups: Botulinum toxin, Botulinum toxin and dilation
Achalasia Clinical Trial 2023: Botulinum toxin type A Highlights & Side Effects. Trial Name: NCT03654066 — Phase 4
Botulinum toxin type A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03654066 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks could be associated with Botulinum toxin and dilation treatment?

"A score of 3 has been assigned to the safety profile of Botulinum toxin and dilation as this is a Phase 4 trial, signifying that it has received approval for medical use."

Answered by AI

Is there currently an effort to bring new participants into this experiment?

"This clinical trial is no longer actively enrolling participants. It was initially posted on May 13th 2019, and the last edit occured on May 2nd 2022. For any prospective patients searching for other trials related to achalasia, 17 studies are currently recruiting; 61 trials involving Botulinum toxin and dilation are likewise actively accepting new enrollees."

Answered by AI

What is the intake capacity for this clinical study?

"At present, this clinical trial has ceased to search for candidates. First posted on May 13th 2019 and last updated on May 2nd 2022, the study is no longer actively recruiting patients. However, there are 17 trials that are presently seeking participants with achalasia and 61 studies which seek individuals for treatment via botulinum toxin or dilation."

Answered by AI

What medical applications are typically associated with Botulinum toxin and dilation?

"Botulinum toxin and dilation are a therapy option for individuals suffering from urinary incontinence, spinal cord damage, botox-related issues, as well as overactive bladder syndrome (OABs)."

Answered by AI

Are there additional investigations that have implemented Botulinum toxin and dilation?

"Presently, there are 61 trials exploring the efficacy of Botulinum toxin and dilation. Of those studies, 20 are in Phase 3 testing. While most experiments pertaining to this treatment take place in Farmington Hills, Michigan; globally 759 medical centres are running related tests."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center Endoscopy Laboratory
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Botox or Botox With Esophageal Dilation in Patients With Achalasia
Dhyanesh Patel 2019. "Botox or Botox With Esophageal Dilation in Patients With Achalasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03654066.
All > Achalasia
~1 spots leftby Jun 2024
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