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Search / Trial NCT03063463

Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Feb 21, 2017

Trial Information

Current as of July 24, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator as part of their routine care will be considered for participation in this study. Blood work, vital signs, and 24-hour dietary recall will be collected over a period of one year. These data will lay the foundation for future scientific endeavors to : a) assess requirements for dietary and/or nutritional supplements; b) formulate an achalasia diet; c) develop clinical practice standards; and d) design an intervention study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Subject is able to provide written informed consent to participate in the study before completing any study-related procedures
  • 2. Subject is male or female aged 18-75 years, inclusive at time of consent.
  • 3. Subject has a documented diagnosis of achalasia based on high resolution manometry and endoscopy report.
  • 4. Subject has been or will be scheduled to undergo either EGD with pneumatic dilation or surgical myotomy as routine care for treatment of achalasia.
  • 5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
  • Exclusion Criteria:
  • 1. Subject has any condition or abnormality, current or past that, in the opinion of the principal investigator, would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of achalasia. Such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; lung transplant; or previous gastroesophageal surgery.
  • 2. Subject has had previous pneumatic dilation of treatment of achalasia.
  • 3. Subject has had botulinum toxin (botox) injection for treatment of achalasia.
  • 4. Subject has a history or high risk of noncompliance with treatment or regular clinic visits.

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Michael Vaezi, MD,PhD

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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