Sensorimotor Dysfunction in Achalasia

NCT02434991 | Withdrawn FDA Device

• 1 other identifier: 14-009073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to assess the esophageal muscle (swallowing tube) in patients with and without achalasia to further understand and help direct the treatment for patients with achalasia.

Conditions

Achalasia

Keywords

trouble swallowing; food sticking; Achalasia

Outcome Measures

Primary Outcomes (1)

• Presence of discomfort during barostat

  During each distention, patients would report presence of discomfort as: 0) none 1) sensation without discomfort 2) mild discomfort 3) moderate discomfort 4) pain. This scale has been utilized in previous studies assessing esophageal mechanosensitivity.

  20 minutes

Secondary Outcomes (1)

• symptoms (followup phone survey)

  3, 6 months, 2, 4 years

Study Arms (1)

Barostat

EXPERIMENTAL

The barostat (a thin tube, with a deflated balloon attached at the end) will be placed through your mouth down your esophagus (swallowing tube) to where your stomach and esophagus meet. The 10-cm long balloon will then be inflated with step by step pressure increases of 4mmHg for 30 seconds each to a maximum pressure of 50mmHg. The patient will rate discomfort during each step of inflation

Device: Barostat

Interventions

Barostat DEVICE

* During this study, the investigators will ask you to fill out questionnaires about your swallowing, chest pain, and heartburn. The investigators hope the patient will answer all of the questions, but patients can skip any questions they do not want to answer. The questionnaires will take about 15 minutes to complete. * A urine pregnancy test for females of childbearing years. * Patients will be asked to fast overnight (nothing to eat or drink for 8 hours) prior to the barostat test. * At this point healthy controls have completed the study. * Patients with achalasia will then undergo treatment for achalasia at the discretion of the primary clinician managing their case. * Patients will be contacted to complete a phone survey 3 \& 6 months and 2 \& 4 years after treatment.

Also known as: Sensorimotor dysfunction

Barostat

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-90
• Patients with achalasia, defined by an esophageal manometry study consistent with the diagnosis

You may not qualify if:

• Patients with EGD or esophagram findings suggestive of pseudoachalasia
• Previous history of pneumatic dilation, Heller myotomy, or botulinum toxin injection to the distal esophagus
• Esophageal diameter greater than 6 cm
• Previous history of upper gastrointestinal surgery
• Medical conditions such as severe heart or lung disease that preclude safe performance barostat
• Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Karthik Ravi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karthik Ravi, M.D.

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: May 6, 2015
• Study Start: March 1, 2018
• Primary Completion: August 14, 2018
• Study Completion: August 14, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

US (1)