Clinical trial NCT05414760: Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier
Official title: Evaluation of Adhesions Formation Using Conventional Third Generation Endometrial Ablation With and Without Postoperative Application of an Intrauterine Adhesion Barrier Film
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asherman Syndrome
Intrauterine Adhesion
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 1
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy endpoint: AFS scale; a discrete number
timeFrame: 4-8 weeks after surgery
measure: Safety endpoint 1.1: Assessment of cavity findings
timeFrame: 4-8 weeks after surgery
measure: Safety endpoint 1.2: Assessment of cavity findings
timeFrame: 4-8 weeks after surgery
measure: Safety endpoint 1.3: Assessment of cavity findings
timeFrame: 4-8 weeks after surgery
measure: Serious adverse events
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Each component of AFS score at second look hysteroscopy
timeFrame: 4-8 weeks after surgery
measure: Binary rate of intrauterine adhesions on hysteroscopy
timeFrame: 4-8 weeks after surgery
measure: Change in menstrual bleeding
timeFrame: 3 months after surgery
measure: Level of dysmenorrhea
timeFrame: Before surgery and after 3 months
measure: Level of patient satisfaction on ablation procedure
timeFrame: Immediately after the surgery
measure: Number of patients complaints
timeFrame: 3 months after surgery
measure: Number of subjects for whom a second ablation is possible
timeFrame: 4-8 weeks after surgery
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Weert
country: Netherlands
facility: St. Jans Gasthuis
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Remko Bosgraaf
role: PRINCIPAL_INVESTIGATOR
References: