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Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma

NCT06274086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-02-23

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:

• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?

Participants will:

* Receive the first session CDS for endometrioma
* Carry the catheter overnight and be monitored in the patient ward
* Receive the second session CDS the next day

Conditions

  • Sclerotherapy
  • Endometrioma

Interventions

PROCEDURE

Two-session catheter-directed sclerotherapy

After receiving the first session of catheter-directed sclerotherapy, each patient carries the catheter overnight and is closely monitored in the patient ward. Then, the patient receives the second session the next day. The catheter is removed after the second session. The procedure was performed under intravenous sedoanalgesia using a combination of 25 mg pethidine hydrochloride and 50 mg fentanyl. Devices used during the procedure included: * An 18-gauge, 20-cm Chiba biopsy needle (Cook, Bloomington, IN, USA); * A 0.035-inch hydrophilic guidewire (Terumo, Tokyo, Japan); * A 7- or 8.5-F pigtail catheter (Dawson-Mueller Drainage Catheter; Cook).

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Ji Hoon Shin, MD, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274086 on ClinicalTrials.gov