Achalasia Clinical Trial
Official title:
Sensorimotor Dysfunction in Achalasia
NCT number | NCT02434991 |
Other study ID # | 14-009073 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2018 |
Est. completion date | August 14, 2018 |
Verified date | August 2018 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 14, 2018 |
Est. primary completion date | August 14, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Adults ages 18-90 - Patients with achalasia, defined by an esophageal manometry study consistent with the diagnosis Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | symptoms (followup phone survey) | Measuring symptoms (dysphagia, regurgitation, chest pain, nocturnal cough) with modified Eckardt Score 0 None 1 occasional 2 daily None Occasional Daily |
3, 6 months, 2, 4 years |
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