Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Womed Leaf group | Active Comparator | Womed 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Womed Leaf | Device | Womed Leafâ„¢ 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 Leafâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-8 weeks after surgery |
| Safety endpoint 1.1: Assessment of cavity findings | Ability to perform a biopsy anywhere within the uterine cavity | 4-8 weeks after surgery |
| Safety endpoint 1.2: Assessment of cavity findings | Ability to adequately visualise the endometrium to evaluate for pathologic change | 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…) | 4-8 weeks after surgery |
| Serious adverse events | Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-8 weeks after surgery |
| Binary rate of intrauterine adhesions on hysteroscopy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Remko Bosgraaf | Catharina Ziekenhuis Eindhoven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Hospital | Eindhoven | 5623EJ | Netherlands | |||
| St. Jans Gasthuis |
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
Immediately after article publication and during 5 years
Researchers who provide a methodologically sound proposal
Not provided
Not provided
| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Yes/ No intrauterine adhesions are present |
| 4-8 weeks after surgery |
| Change in menstrual bleeding | Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart | 3 months after surgery |
| Level of dysmenorrhea | Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms | 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 | Immediately after the surgery |
| Number of patients complaints | Number of patient complaints (i.e. complaints related to discharge or dyspareunia) | 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. | 4-8 weeks after surgery |
| Weert |
| 6001BE |
| Netherlands |
| D000091662 | Genital Diseases |