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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03356067
Eligibility Criteria:
Inclusion Criteria:
* Refractory (\> 6 months) and severe (based on a validated total GSCI = 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 4 months prior to enrolment), or confirmed by a validated gastric emptying breath test \[27\]. The total GSCI score must be \>2.3 \[28\].
* 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.
* Radiolabelled liquids emptying study will be reserved as alternative technique for patients with poor tolerance of solids during scintigraphy. Abnormal gastric emptying will represent \>50% retention of radiolabelled content (e.g. In-111) at 1 hour.
* Abnormal gastric empyting breath test based on a solid normal range determination for the test used (e.g. T1/2 \> 109 min)
Exclusion Criteria:
* Age less than 18 years
* No previous attempt with at least one prokinetic drug
* No previous attempt to withdraw anticholinergic agents and glucagon like peptide -1 (GLP-1) and amylin analogues\* in patients treated with these substances
* Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment.
* Previous gastric surgery BI or II, esophagectomy, gastric pull-through
* Previous pyloromyotomy or pyloroplasty
* Known eosinophilic gastroenteritis
* Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
* Severe coagulopathy
* Esophageal or gastric varices and /or portal hypertensive gastropathy
* Advanced liver cirrhosis (Child B or Child C)
* Active peptic ulcer disease
* Pregnancy or puerperium
* Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST)
* Any other condition, which in the opinion of the investigator would interfere with study requirements
* Uncontrolled diabetes mellitus
* Diagnosis of rumination syndrome or "eating" disorder (mental anorexia, bulimia nervosa) \*\*
* Severe constipation without using laxatives
* Inability to obtain informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03356067
Study Brief:
Protocol Section:
NCT03356067