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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT03679104
Eligibility Criteria:
Inclusion Criteria:
1. Refractory (\> 6 months) and severe (based on a validated total Gastroparesis Cardinal Symptom Index) gastroparesis, with confirmed gastric emptying based on a gastric emptying study: standardized protocol of scintigraphy in all patients (performed less than 6 months prior to enrolment). The total GSCI (Gastroparesis Cardinal Symptom Index) score must be \>2.0
* Abnormal gastric emptying is defined as retention of Tc-99 m \>60% at 2 h and/or ≥10% of residual activity at 4 h on a standardized sulphur colloid solid-phase gastric emptying study.
* Abnormal gastric emptying breath test based on a solid normal range determination for the test used (e.g. T1/2 \> 109 min)
2. Severe refractory disease is defined as GCSI \>2.0 and failure or recurrence in patients who received available optimal pharmacological therapies.
3. Persons 18 years or older at the time of signing the informed consent
4. Signed informed consent
Exclusion Criteria:
1. No previous attempt with at least one prokinetic drug
2. No previous attempt to withdraw anticholinergic agents and glucagon like peptide -1 (GLP-1) and amylin analogues in patients treated with these substances
3. Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
4. Previous gastric surgery (Billroth I or Billroth II)
5. Known eosinophilic gastroenteritis
6. Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
7. Sever coagulopathy
8. Oesophageal or gastric varices and /or portal gastropathy
9. Advanced liver cirrhosis (Child B or Child C)
10. Active peptic ulcer disease
11. Pregnancy or puerperium
12. Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment
13. Any other condition, which in the opinion of the investigator would interfere with study requirements
14. Uncontrolled diabetes mellitus
15. Diagnosis of rumination syndrome or "eating" disorder (mental anorexia, bulimia nervosa)
16. Inability to obtain informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03679104
Study Brief:
Protocol Section:
NCT03679104