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Search / Trial NCT06988280

Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · May 22, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Adnexal Cyst Transvaginal Aspiration Cyst Recurrence Pelvic Abscess Symptom Relief

ClinConnect Summary

This clinical trial is studying a procedure called ultrasound-guided transvaginal aspiration, which is a way to drain fluid from cysts and abscesses in the pelvic area. These cysts can cause discomfort, especially in women, and sometimes they may even lead to more serious complications. The trial aims to find out how well this procedure helps relieve symptoms and whether the cysts come back after treatment. It is also looking into how safe the procedure is and how patients feel during and after it.

To be eligible for this study, participants should be women aged 18 and older who have specific types of cysts or abscesses that can be safely accessed with the procedure. Those who are not eligible include women with certain health issues or specific types of lesions that may pose a higher risk. If you join the trial, you can expect a minimally invasive procedure that might provide quick relief without the need for more invasive surgery. This study is important because it could help improve treatment options for women experiencing these uncomfortable conditions.

Gender

FEMALE

Eligibility criteria

  • Participants eligible for inclusion in this study must meet all of the following criteria:
  • 1. Lesion criteria applicable for therapeutic intervention
  • 1. Safe accessibility of the lesion (within reach of aspiration needle; visible on ultrasound; transvaginal access; no interposition of bowel or blood vessels)
  • 2. Lesion types included: cystic lesions (adnexal cysts), pelvic inclusion cysts (pseudocysts), pelvic abscesses
  • 2. Indications
  • 1. Pain relief in symptomatic cystic lesions with benign appearance.
  • 2. Symptomatic treatment in probably malignant lesions (only in non-curative setting).
  • Exclusion Criteria:
  • 1. Patients \<18 years
  • 2. Poor performance status contra-indicating the procedure
  • 3. Vaginal stenosis (severe atrophy - virgo - vaginismus)
  • 4. Purely solid lesions
  • 5. Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting
  • 6. Physiological cysts in asymptomatic patients (in case of doubt the patient is reassessed after 3-6 months)

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported