SclerotherapyNCT06274086
Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma
A study testing Two-session catheter-directed sclerotherapy in people with Sclerotherapy and Endometrioma, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sclerotherapy, Endometrioma
- What is being tested?
- Two-session catheter-directed sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Symptom manifestation as endometriosis (i.e., dysmenorrhea, dyspareunia, and lower abdominal or pelvic pain)
- Endometrioma ≥ 3 cm confirmed on ultrasound
- No evidence of solid lesions on ultrasound
- No suspected extraovarian endometriosis
Who cannot join
- History of gynecologic malignancy
- Active inflammation or infection
- Abnormal coagulation profile
- Loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Clinical Outcomes of Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma
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
Read the detailed description
Catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. However, whether the sclerosing agent should be retained inside the endometrioma was controversial. To increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.
- Conditions
- Sclerotherapy, Endometrioma
- Being tested
- Two-session catheter-directed sclerotherapy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-session catheter-directed sclerotherapyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Two-session catheter-directed sclerotherapy | Experimental | Each patient received two sessions of catheter-directed sclerotherapy for endometrioma 1 day apart with the catheter left in situ overnight. Receives: Procedure: Two-session catheter-directed sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence of endometrioma was assessed
Measured: Recurrence was assessed at 1, 3, and 6 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Jun 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hoon Shin, Asan Medical Center
- Investigators
- Ji Hoon Shin, MD, PhD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274086
- Sponsor's protocol ID
- S2022-2027-0001
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Outcomes of Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma
- ClinicalTrials.gov ID
- NCT06274086
- Acronym / sponsor ID
- S2022-2027-0001
- Conditions
- Sclerotherapy, Endometrioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. However, whether the sclerosing agent should be retained inside the endometrioma was controversial. To increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two-session catheter-directed sclerotherapy | Experimental | Procedure: Two-session catheter-directed sclerotherapyEach patient received two sessions of catheter-directed sclerotherapy for endometrioma 1 day apart with the catheter left in situ overnight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years
- Symptom manifestation as endometriosis (i.e., dysmenorrhea, dyspareunia, and lower abdominal or pelvic pain)
- Endometrioma ≥ 3 cm confirmed on ultrasound
- No evidence of solid lesions on ultrasound
- No suspected extraovarian endometriosis
Key exclusion criteria (4 listed)
- History of gynecologic malignancy
- Active inflammation or infection
- Abnormal coagulation profile
- Loss to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-session catheter-directed sclerotherapyAfter 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). | Procedure or surgery | Two-session catheter-directed sclerotherapy |
Primary outcome
Recurrence
Time frame: Recurrence was assessed at 1, 3, and 6 months after the procedure.
Recurrence of endometrioma was assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Hoon Shin, MD, PhD study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-session catheter-directed sclerotherapy in people with Sclerotherapy and Endometrioma, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: Recurrence was assessed at 1, 3, and 6 months after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.