Intrauterine Adhesion Clinical Trial
— CLEANOfficial title:
Evaluation of Adhesions Formation Using Conventional Third Generation Endometrial Ablation With and Without Postoperative Application of an Intrauterine Adhesion Barrier Film
Verified date | February 2024 |
Source | Catharina Ziekenhuis Eindhoven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
Status | Completed |
Enrollment | 1 |
Est. completion date | February 5, 2024 |
Est. primary completion date | February 5, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Catharina Hospital | Eindhoven | |
Netherlands | St. Jans Gasthuis | Weert |
Lead Sponsor | Collaborator |
---|---|
Remko P. Bosgraaf |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Safety endpoint 1.1: Assessment of cavity findings | Ability to perform a biopsy anywhere within the uterine cavity | 4-8 weeks after surgery | |
Primary | Safety endpoint 1.2: Assessment of cavity findings | Ability to adequately visualise the endometrium to evaluate for pathologic change | 4-8 weeks after surgery | |
Primary | 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 | |
Primary | Serious adverse events | Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome. | 3 months after surgery | |
Secondary | 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 | |
Secondary | Binary rate of intrauterine adhesions on hysteroscopy | Yes/ No intrauterine adhesions are present | 4-8 weeks after surgery | |
Secondary | Change in menstrual bleeding | Change in menstrual bleeding using Pictorial Blood Loss Assessment Chart | 3 months after surgery | |
Secondary | Level of dysmenorrhea | Painful cramping associated with menstruation; 0 = no symptoms and 5 = very severe symptoms | Before surgery and after 3 months | |
Secondary | 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 | |
Secondary | Number of patients complaints | Number of patient complaints (i.e. complaints related to discharge or dyspareunia) | 3 months after surgery | |
Secondary | 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 |
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