Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System

Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate pregnancies following the Acessa™ treatment of uterine myomas in women who desire future childbearing

Study Overview

• Status: Completed
• Conditions: One or More Uterine Fibroids
• Intervention / Treatment: Device: radiofrequency generator

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • University Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Are premenopausal and aged 18 to 40 years.
2. Have already consented to have their fibroids treated with the Acessa™ procedure.
3. Desire pregnancy within two years following Acessa™ treatment
4. Have a normal endometrial cavity as delineated by sonohysterogram within 6 months prior to treatment.
5. Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory pelvic exam.

6. Have fibroids identified by transvaginal ultrasound with:

   1. ≤6 (six) fibroids of ≤5 cm at the major diameter
   2. a total uterine volume of no greater than 300 cc
7. Patients with type 2 fibroids are acceptable for inclusion.
8. Are current in their screening for cervical cancer precursors (i.e. PAP 1 or 2).
9. Are capable of providing informed consent.
10. Are willing and able to comply with all study tests, procedures, and assessment tools during screening and up to 3 years post treatment.
11. Are able to pass a pre-operative health exam (ASA I-III).
12. Patients who are currently undergoing fertility treatments (e.g. Clomid, IVF, etc.) or who are planning such treatments may be enrolled in the study.

Exclusion Criteria:

1. Have contraindications for laparoscopic surgery and/or general anesthesia.
2. Have cervical myomas or Type 0 or Type 1 myomas. Type 0 and Type 1 myomas are excluded as these are generally accessible to hysteroscopic approaches. Cervical myomas are difficult to treat and present a greater risk of bladder or urethral injury.
3. Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous fibroids.
4. Have known or suspected abdominal adhesions which are expected to complicate laparoscopic surgery.
5. Have known or suspected untreated intra-uterine adhesions or uterine septum.
6. Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation/occlusion, high-intensity focused ultrasound, laparoscopic, hysteroscopic or abdominal myomectomy, or any other uterine-preserving technique for reduction of menstrual bleeding.
7. Subjects taking platelet-inhibiting drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and clopidogrel
8. Are pregnant or lactating.
9. Have known or suspected severe endometriosis.
10. Have known or suspected adenomyosis.
11. Have active or history of pelvic inflammatory disease.
12. Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years.
13. Have had pelvic radiation.
14. Have a persistent and undiagnosed complex adnexal mass.Are unable to give informed consent.
15. In the medical judgment of the investigator should not participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acessa™ System; radiofrequency generator	Device: radiofrequency generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous abortion		6 months
Ectopic pregnancy		three years
Vaginal delivery and either	i. Uncomplicated delivery or ii. Delivery with complications such as: Premature rupture of the membranes (PROM) or; Preterm premature rupture of the membranes (PPROM)	three years
Caesarean section delivery and either	i. Uncomplicated delivery or ii. Delivery with complications such as: Preterm delivery; Preterm labor; Uterine rupture; Stillbirths; Postpartum	three years

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedure-related complications within 1 month post-procedure	1 month
Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie	1 month
Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score	three years
Post-treatment changes in myoma size as determined by ultrasound	3, 6, 36 months

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Sara Y Brucker, MD, University Women's Hospital, Calwerstrasse 7, 72076 Tübingen, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): August 13, 2023

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimated): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: GFA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO