Mechanisms of Weight Loss in Patients Diagnosed With Achalasia
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|ClinicalTrials.gov Identifier: NCT03063463|
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment|
|Achalasia||Procedure: pneumatic dilation Procedure: surgical myotomy|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Mechanisms of Weight Loss in Patients Diagnosed With Achalasia: A Prospective Observational Study|
|Actual Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2020|
Subject with achalasia undergoing routine care EGD (Esophagogastroduodenoscopy) with pneumatic dilation
Procedure: pneumatic dilation
Pneumatic dilation of the lower esophageal sphincter (LES) consists of inserting a guide wire under visual control into the stomach and to pass the balloon over the guide wire. The balloon is inflated, disrupting the muscle fibers of the sphincter.
Subject with achalasia undergoing routine care EGD with surgical myotomy
Procedure: surgical myotomy
This procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.
- Body weight [ Time Frame: One year ]Currently there are no existing data to determine why some achalasia patients lose weight while others do not. The purpose of this study is to determine if differences may be identified between those who lose weight and those who do not. Body weight will be monitored at study visits throughout the study.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063463
|Contact: Amy Motleyfirstname.lastname@example.org|
|Contact: Tina Higginbothamemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Amy Motley 615-322-6281 firstname.lastname@example.org|
|Contact: Tina Higginbotham 615-322-4643 email@example.com|
|Principal Investigator: Michael Vaezi, MD, PhD|
|Principal Investigator:||Michael Vaezi, MD,PhD||Vanderbilt University Medical Center|