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:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT01560559
Eligibility Criteria:
Inclusion Criteria:
1. Patients of both sexes aged over 18 years old
2. Patients who have signed the informed consent form before any study related procedure
3. Primary achalasia of the cardia with Eckardt score \> 3
4. Non sigmoid achalasia or S1 sigmoid type achalasia at barium meal Rx study
5. ASA score (American Society of Anaesthesiologists) 1 or 2
6. Patients affiliated to a social security health system
Exclusion Criteria:
1. Patients with age less than 18 years old
2. Patients without discernment with legal protection
3. Patients who will not be able to abide with study follow-up as judged by the investigator
4. Patients which cannot provide a written informed consent
5. Patient refusing to participate in the study, without informed consent
6. Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βHCG test
7. Concomitant participation in other clinical trial
8. S2 sigmoid type primitive achalasia of the cardia
9. Pseudo-achalasia (esophageal carcinoma),
10. History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus
11. History of esophageal strictures, systemic sclerosis
12. History of esophageal varices
13. History of endoscopic or surgical therapy of the esophageal achalasia
14. History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands)
15. History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage)
16. History of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (TP \< 60%, TCA \> 40 seconds, platelets \< 60000/mmc)
17. ASA score (American Society of Anaesthesiologists) 3, 4, 5 or 6
18. Cancer, liver, respiratory, renal or heart failure which put the patients in the ASA risk group 3,4,5 or 6.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01560559
Study Brief:
Protocol Section:
NCT01560559