Evaluation of adhesions formation using conventional third generation endometrial ablation with and without postoperative application of an intrauterine adhesion barrier film

Phase 3

Completed

• Conditions: Intra-uterine adhesions; 10062915

• Registration Number: NL-OMON51498
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Patient with refractory heavy menstrual bleeding scheduled for endometrial
ablation with NovaSure system
2.Women 30 years old or older;
3.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.
4.Subjects who can comply with the study follow-up and other study
requirements.

Exclusion Criteria

1. Cavity length <4 or >8
2. Perforation during the ablation procedure
3. Previous adhesiolysis procedure or diagnosis of Asherman's disease.
4. An abnormal uterine cavity at the time of ablation according to ESHRE
classification I to V, such as unicornis, bicornis, septate, duplex
5. Medical history of cervical or endometrial cancer
6. Active pelvic infection or medical history of pelvic peritonitis
7. An intrauterine device in situ
8. Known contraindication or hypersensitivity to PEO or PLA
9. Current participation in another clinical investigation that has not yet
received the primary endpoint
10. Any other condition that makes participation in the study contrary to the
patient*s best interests.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary efficacy endpoint:<br /><br>AFS score focused on the intrauterine adhesion formation following Novasure<br /><br>(i.e. considering only extent of cavity involved and type of adhesions after)<br /><br>at 4-6 weeks<br /><br><br /><br>Primary safety endpoints:<br /><br>1. Assessment of cavity findings at 4-6 weeks<br /><br>a. Ability to perform a biopsy anywhere within the uterine cavity<br /><br>b. Ability to adequately visualise the endometrium to evaluate for pathologic<br /><br>change<br /><br>c. Qualitative description of the endometrial cavity (i.e. presence of viable<br /><br>endometrium vs cicatricial/fibrotic tissue*)<br /><br><br /><br>2. Number of Serious Adverse Events and Serious Device-related Adverse Events<br /><br>at 3 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Each component of AFS score at second look hysteroscopy: extent of IUA, type<br /><br>of IUA<br /><br>2. Binary rate of intrauterine adhesions on hysteroscopy<br /><br>3. Change in menstrual bleeding at 3 months using Pictorial Blood Loss<br /><br>Assessment Chart<br /><br>4. Level of dysmenorrhea before and after 3 months (painful cramping associated<br /><br>with menstruation)<br /><br>5. Level of patient satisfaction on ablation procedure on a scale from 0 to 5<br /><br>from the worst to the best health care possible.<br /><br>6. Patients complaints (discharge, dyspareunia)<br /><br>7. Is it possible to perform a second ablation procedure in case needed?<br /><br>8. Histopathology assessment of hysterectomy piece (in the case a<br /><br>hysterectomy is performed few years after endometrial ablation)<br /><br>9. Histopathology assessment of endometrial biopsy taken at second look<br /><br>hysteroscopy</p><br>