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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT07272720
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Single kidney stone (6 - 15 mm) in the target kidney
3. Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU
Exclusion Criteria:
1. BMI \> 29.9
2. Target stone that cannot be localised
3. Multiple kidney stones in the target kidney
4. Stones with a density value of \> 1,200 HU
5. Skin to stone distance (SSD) \> 160 mm
6. The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:
1. Skeletal malformations and obesity, preventing targeting of the stone
2. Malignant tumour in the shockwave path
3. Arterial aneurysm or calcium deposits, or thrombosis in shockwave path
4. Brain, spinal column or air-filled tissue, especially the lungs, in the shockwave path
5. Obstruction distal to the stone (as this would hinder the passage of fragments through collecting system or ureter)
7. Any disease/medical condition, prior or concomitant medication/treatment/intervention, or implant that may affect this clinical investigation, and/or is contraindicated for the IMD, including but not limited to the following:
1. Severe nephrocalcinosis
2. Uncontrolled urinary tract infection
3. Coagulation disorders and bleeding diathesis, not compensated according to urological and hemostaseological guidelines
4. Anticoagulation or platelet inhibition therapy, not bridged according to urological and hemostaseological guidelines
5. Uncontrolled hypertension
6. Blood pressure \> 180/100
7. Active cardiac implants that are not authorized for use with ESWL
8. Pancreatitis
9. Ehlers-Danlos syndrome
10. Administration of contrast agents containing gases for ultrasound diagnostics less than 24 hours before treatment.
8. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07272720
Study Brief:
Protocol Section:
NCT07272720