Asherman Syndrome, Intrauterine Adhesion
Conditions
Brief summary
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.
Interventions
DEVICEWomed Leaf
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.
Sponsors
Remko P. Bosgraaf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint: AFS scale; a discrete number | 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 | 4-8 weeks after surgery | Ability to perform a biopsy anywhere within the uterine cavity |
| Safety endpoint 1.2: Assessment of cavity findings | 4-8 weeks after surgery | Ability to adequately visualise the endometrium to evaluate for pathologic change |
| Safety endpoint 1.3: Assessment of cavity findings | 4-8 weeks after surgery | Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue…) |
| Serious adverse events | 3 months after surgery | Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients complaints | 3 months after surgery | Number of patient complaints (i.e. complaints related to discharge or dyspareunia) |
| Each component of AFS score at second look hysteroscopy | 4-8 weeks after surgery | 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. |
| Number of subjects for whom a second ablation is possible | 4-8 weeks after surgery | For each subject, the second look evaluator will assess whether it is possible to perform a second ablation if needed. |
| Binary rate of intrauterine adhesions on hysteroscopy | 4-8 weeks after surgery | Yes/ No intrauterine adhesions are present |
| Change in menstrual bleeding | 3 months after surgery | Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart |
| Level of dysmenorrhea | Before surgery and after 3 months | Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms |
| Level of patient satisfaction on ablation procedure | Immediately after the surgery | 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 |
Countries
Netherlands
Outcome results
None listed