Status:
RECRUITING
Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Pelvic Abscess
Adnexal Cyst
Eligibility:
FEMALE
18+ years
Brief Summary
Adnexal cysts or pseudocysts are a common finding on transvaginal ultrasound, especially in premenopausal women. Due to the size of some cysts, they may cause discomfort. Moreover, a genuine risk of o...
Eligibility Criteria
Inclusion
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Lesion criteria applicable for therapeutic intervention
- Safe accessibility of the lesion (within reach of aspiration needle; visible on ultrasound; transvaginal access; no interposition of bowel or blood vessels)
- Lesion types included: cystic lesions (adnexal cysts), pelvic inclusion cysts (pseudocysts), pelvic abscesses
- Indications
- Pain relief in symptomatic cystic lesions with benign appearance.
- Symptomatic treatment in probably malignant lesions (only in non-curative setting).
- Exclusion Criteria:
- Patients \<18 years
- Poor performance status contra-indicating the procedure
- Vaginal stenosis (severe atrophy - virgo - vaginismus)
- Purely solid lesions
- Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting
- Physiological cysts in asymptomatic patients (in case of doubt the patient is reassessed after 3-6 months)
Exclusion
Key Trial Info
Start Date :
March 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06988280
Start Date
March 13 2025
End Date
December 1 2028
Last Update
May 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000