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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT00565604
Eligibility Criteria:
Inclusion Criteria:
1. The subject is 18 years of age or older.
2. The subject has the presence of incompetent perforator veins measuring \> 3 mm in diameter resultant of reflux documented on duplex ultrasound.
3. The subject has a CEAP classification of 3, 4, 5 or 6.
4. The subject has incompetent perforator veins that are superior to the foot and distal ankle.
5. The subject is willing and able to provide appropriate informed consent.
6. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
Exclusion Criteria:
1. The subject has a history of significant arterial disease.
2. The subject is known to be, or suspected to be, pregnant (verified in a manner consistent with institution's standard of care), or is lactating.
3. The subject has an Ankle Brachial Index (ABI) of \< 0.5
4. The subject has occlusive thrombosis in the vein segment to be treated.
5. The subject has acute deep vein thrombosis.
6. The subject has an active or systemic infection.
7. The subject is or was enrolled in another investigational device or drug trial that may interfere with the results of this trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00565604
Study Brief:
Protocol Section:
NCT00565604