Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03228758
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who have been diagnosed with Achalasia Type I, II, or III by positive manometric findings and supporting findings by timed barium esophagram and endoscopy.
2. Subjects who are willing and competent to sign Informed Consent and to comply with study related visits and procedures.
Exclusion Criteria:
1. Subjects who are under 18 years of age
2. Subjects with Achalasia Type I, II, or III who have had a prior failed open or laparoscopic Heller myotomy; or have an esophageal diverticula, or anatomical variant dictating the approach of the myotomy
3. Subjects diagnosed with other motility disorders such as distal esophageal spasm (DES), hypertensive peristalsis (Nutcracker), or hypercontractile esophagus (Jackhammer)
4. Subjects with coagulopathy
5. Pregnant females
6. Subjects who in the investigators' opinion, are medically unstable , are unable to give informed consent, or whose risks outweigh the benefits of participating in the study
7. Subjects with decisional incapacity who are unable to comply with study related visits and procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03228758
Study Brief:
Protocol Section:
NCT03228758