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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT02663206
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients age 18 - 80 years old.
2. Spastic disorders of the esophagus include spastic (type III) achalasia, distal esophageal spasm (DES), and hypercontractile (jackhammer) esophagus via high resolution esophageal manometry (HRM) 2.
* DES is characterized by normal esophagogastric junction relaxation (integrated relaxation pressure \[IRP\] \<15 mm Hg) and ≥ 20% premature contractions.
* Spastic achalasia is defined as impaired EGJ relaxation (IRP ≥15 mm Hg) associated with ≥ 20% premature contractions.
* The diagnosis of jackhammer esophagus is defined as at least 1 swallow with a distal contractile integral (DCI) greater than 8000 mm Hg- s- cm.
3. At least 6 months of symptoms (chest pain, dysphagia, regurgitation and/or weight loss) with no adequate response or intolerance to medical therapy including nitrates and/or calcium channel blockers.
4. Overall symptoms score (Eckardt score) \> 3
5. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Diagnosis of spastic esophageal disorder was not confirmed by HRM testing.
2. Previous surgery of the esophagus or stomach
3. Previous BTX injection at the esophagogastric junction (EGJ) or LES.
4. Active severe esophagitis
5. Large lower esophageal diverticula
6. Large \> 3cm hiatal hernia
7. Megaesophagus (\> 6 cm)
8. Sigmoid esophagus
9. Known gastroesophageal malignancy
10. Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
11. Cirrhosis with portal hypertension, varices, and/or ascites
12. Uncorrectable coagulopathy defined by prothrombin time \< 50% of control; partial thromboplastin time (PTT) \> 50 sec, or international normalized ratio (INR) \> 1.5), on chronic anticoagulation, or platelet count \<75,000.
13. Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02663206
Study Brief:
Protocol Section:
NCT02663206