Asherman SyndromeCLEANNCT05414760
Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier
A study testing Womed Leaf in people with Asherman Syndrome and Intrauterine Adhesion, run by Remko P. Bosgraaf at 2 sites in Netherlands.
Trial summary
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Asherman Syndrome, Intrauterine Adhesion
- What is being tested?
- Womed Leaf
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesNetherlands
- Study dates
- 11 Nov 2022to 5 Feb 2024
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
- Women 30 years old or older;
- Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
- Subjects who can comply with the study follow-up and other study requirements.
Who cannot join
- Cavity length <4 or >8
- Perforation during ablation procedure
- Previous adhesiolysis procedure or diagnosis of Asherman's disease.
- Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
- History of cervical or endometrial cancer
- Active pelvic infection or history of pelvic peritonitis
Show all 9Show fewer
- Known contraindication or hypersensitivity to Womed Leaf component
- Current participation in another clinical investigation that has not yet received the primary endpoint
- Any other condition that makes participation in the study contrary to the patient's best interests.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Catharina Hospital
Eindhoven, 5623EJ
St. Jans Gasthuis
Weert, 6001BE
About this study
Official title: Evaluation of Adhesions Formation Using Conventional Third Generation Endometrial Ablation With and Without Postoperative Application of an Intrauterine Adhesion Barrier Film
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
Read the detailed description
The application of endometrial ablation (EA) has significantly increased in the past 10 years. It is an effective treatment for heavy menstrual bleeding with functional aetiology. However, the risk of post-ablative intracavitary scarring after EA is significant and can lead to long term complications, and the possible delay in diagnosing endometrial cancer. CLEAN is a prospective, multi-center, randomized, controlled, two arm pilot clinical trial. The objective is to compare the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
The study will be performed on women with heavy menstrual bleeding (menorrhagia) scheduled for thermal endometrial ablation with Novasure system (Hologic) A follow-up diagnostic hysteroscopy will be performed 4-8 weeks after the ablation procedure to determine the presence and severity of IUAs according to the American Fertility Society.
- Conditions
- Asherman Syndrome, Intrauterine Adhesion
- Being tested
- Womed Leaf
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Womed LeafDevice
Womed Leaf™ is a sterile, degradable film of poly(D,L-lactide) (PLA) and poly(ethylene oxide) (PEO). PEO is a biocompatible polymer with anti-adhesion and swelling properties. It is polymerized with hydrophobic PLA to form a degradable film. Womed Leaf™ is inserted in the uterine cavity by a gynaecologist surgeon with a 5 mm diameter flexible inserter. Once released, the film unfolds and grows into the uterine cavity to create a mechanical barrier and keep the uterine walls separated for approximately one week. It is then degraded and discharged naturally through the cervix.
| Study group | Role | What they receive |
|---|---|---|
| Womed Leaf group | Active comparator | Womed Leaf is inserted immediately after completion of the endometrial ablation. Receives: Device: Womed Leaf |
| No adhesion prevention group | No intervention | Standard of care: no IUA prevention, no placebo after ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint: AFS scale; a discrete number
Focused on the intrauterine adhesion formation following Novasure (i.e. considering only extent of cavity involved and type of adhesions) Extent of IUA => 1 = less than 1/3 of the cavity involved and 4 = more than 2/3.
Type of IUA => 1 = filmy and 4 = dense. Sum: 1 = very light adhesions and 12 = extremely severe adhesions obstructing the whole cavity.
Measured: 4-8 weeks after surgery
Safety endpoint 1.1: Assessment of cavity findings
Ability to perform a biopsy anywhere within the uterine cavity
Measured: 4-8 weeks after surgery
Safety endpoint 1.2: Assessment of cavity findings
Ability to adequately visualise the endometrium to evaluate for pathologic change
Measured: 4-8 weeks after surgery
Safety endpoint 1.3: Assessment of cavity findings
Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue…)
Measured: 4-8 weeks after surgery
Serious adverse events
Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome.
Measured: 3 months after surgery
Secondary outcomes (7)
Each component of AFS score at second look hysteroscopy
Extent of IUA => 1 = less than 1/3 of the cavity involved and 4 = more than 2/3.
Type of IUA => 1 = filmy and 4 = dense.
Measured: 4-8 weeks after surgery
Binary rate of intrauterine adhesions on hysteroscopy
Yes/ No intrauterine adhesions are present
Measured: 4-8 weeks after surgery
Change in menstrual bleeding
Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart
Measured: 3 months after surgery
Level of dysmenorrhea
Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms
Measured: Before surgery and after 3 months
Level of patient satisfaction on ablation procedure
On a scale from 0 to 5 from the worst to the best health care possible; 0 = worst health care possible and 5 = best health care possible
Measured: Immediately after the surgery
Number of patients complaints
Number of patient complaints (i.e. complaints related to discharge or dyspareunia)
Measured: 3 months after surgery
Number of subjects for whom a second ablation is possible
For each subject, the second look evaluator will assess whether it is possible to perform a second ablation if needed.
Measured: 4-8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start11 Nov 2022
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asherman SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Remko P. Bosgraaf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Remko P. Bosgraaf, Catharina Ziekenhuis Eindhoven
- Investigators
- Remko Bosgraaf, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414760
- Sponsor's protocol ID
- CLEAN
- Acronym
- CLEAN
- Status last verified
- Feb 2024
- First submitted
- 29 May 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized data will become available and reusable for other researchers upon reasonable request according to GCP and FAIR principles. All research data will be handled confidentially in accordance with legislation and conditions imposed by Autoriteit Persoonsgegevens. Individual participant data that underlie the result that will be reported in an article and study protocol may be made available to researchers who provide a methodologically sound proposal, immediately after article publication and during 5 years
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adhesions Formation Using Conventional Third Generation Endometrial Ablation With and Without Postoperative Application of an Intrauterine Adhesion Barrier Film
- ClinicalTrials.gov ID
- NCT05414760
- Acronym / sponsor ID
- CLEAN / CLEAN
- Conditions
- Asherman Syndrome, Intrauterine Adhesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Remko P. BosgraafUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jun 2022 (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.
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
Detailed description
The application of endometrial ablation (EA) has significantly increased in the past 10 years. It is an effective treatment for heavy menstrual bleeding with functional aetiology. However, the risk of post-ablative intracavitary scarring after EA is significant and can lead to long term complications, and the possible delay in diagnosing endometrial cancer. CLEAN is a prospective, multi-center, randomized, controlled, two arm pilot clinical trial. The objective is to compare the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
The study will be performed on women with heavy menstrual bleeding (menorrhagia) scheduled for thermal endometrial ablation with Novasure system (Hologic) A follow-up diagnostic hysteroscopy will be performed 4-8 weeks after the ablation procedure to determine the presence and severity of IUAs according to the American Fertility Society.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Womed Leaf group | Active comparator | Device: Womed LeafWomed Leaf is inserted immediately after completion of the endometrial ablation. |
| No adhesion prevention group | No intervention | –Standard of care: no IUA prevention, no placebo after ablation |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
- Women 30 years old or older;
- Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
- Subjects who can comply with the study follow-up and other study requirements.
Key exclusion criteria (9 listed)
- Cavity length <4 or >8
- Perforation during ablation procedure
- Previous adhesiolysis procedure or diagnosis of Asherman's disease.
- Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
- History of cervical or endometrial cancer
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 |
|---|---|---|
| Womed LeafWomed Leaf™ is a sterile, degradable film of poly(D,L-lactide) (PLA) and poly(ethylene oxide) (PEO). PEO is a biocompatible polymer with anti-adhesion and swelling properties. It is polymerized with hydrophobic PLA to form a degradable film. Womed Leaf™ is inserted in the uterine cavity by a gynaecologist surgeon with a 5 mm diameter flexible inserter. Once released, the film unfolds and grows into the uterine cavity to create a mechanical barrier and keep the uterine walls separated for approximately one week. It is then degraded and discharged naturally through the cervix. | Device | Womed Leaf group |
Primary outcome
Efficacy endpoint: AFS scale; a discrete number
Time frame: 4-8 weeks after surgery
Focused on the intrauterine adhesion formation following Novasure (i.e. considering only extent of cavity involved and type of adhesions) Extent of IUA => 1 = less than 1/3 of the cavity involved and 4 = more than 2/3. Type of IUA => 1 = filmy and 4 = dense. Sum: 1 = very light adhesions and 12 = extremely severe adhesions obstructing the whole cavity.
Safety endpoint 1.1: Assessment of cavity findings
Time frame: 4-8 weeks after surgery
Ability to perform a biopsy anywhere within the uterine cavity
Safety endpoint 1.2: Assessment of cavity findings
Time frame: 4-8 weeks after surgery
Ability to adequately visualise the endometrium to evaluate for pathologic change
Safety endpoint 1.3: Assessment of cavity findings
Time frame: 4-8 weeks after surgery
Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue…)
Serious adverse events
Time frame: 3 months after surgery
Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome.
7 secondary outcomes
Each component of AFS score at second look hysteroscopy
Time frame: 4-8 weeks after surgery
Binary rate of intrauterine adhesions on hysteroscopy
Time frame: 4-8 weeks after surgery
Change in menstrual bleeding
Time frame: 3 months after surgery
Level of dysmenorrhea
Time frame: Before surgery and after 3 months
Level of patient satisfaction on ablation procedure
Time frame: Immediately after the surgery
Number of patients complaints
Time frame: 3 months after surgery
Number of subjects for whom a second ablation is possible
Time frame: 4-8 weeks after surgery
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 7 Feb 2024.
- Individual participant dataSharing planned: Yes. The anonymized data will become available and reusable for other researchers upon reasonable request according to GCP and FAIR principles. All research data will be handled confidentially in accordance with legislation and conditions imposed by Autoriteit Persoonsgegevens. Individual participant data that underlie the result that will be reported in an article and study protocol may be made available to researchers who provide a methodologically sound proposal, immediately after article publication and during 5 years
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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.
Remko Bosgraaf principal investigator
Catharina Ziekenhuis Eindhoven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Womed Leaf in people with Asherman Syndrome and Intrauterine Adhesion, run by Remko P. Bosgraaf at 2 sites in Netherlands.
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 4 inclusion and 9 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 7 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 2 sites in Netherlands. 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?
Efficacy endpoint: AFS scale; a discrete number (time frame: 4-8 weeks after surgery). The study lists 5 primary outcomes in all. 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 7 Feb 2024.