NCT04003428

Feasibility of HIFU for Management of Placenta Accreta (HIFU-ACCRETA)

Perioperative Evaluation of High Intensity Focalized Ultrasound for Adjuvant Management of Placenta Accreta: a Clinical Feasibility Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Placental accretion during pregnancy refers to an abnormally deep insertion of the placenta into the uterus, leading to the impossibility of removing the placenta without inducting uterine or surrounding organs lesions. The management of these patients is complex, with two options during caesarean section: hysterectomy or uterine conservative surgery in which the placenta is let in the uterine cavity. These are both at risk of complications, including severe hemorrhage. High Intensity Focused Ultrasound (HIFU) principle is based on the focusing of ultrasonic waves in a focal zone causing a rapid rise in temperature in the targeted area. This focus results in the creation of a coagulation necrosis tissue lesion. This procedure is guided in real time by an integrated ultrasound imaging cell. The investigators hypothesized that HIFU shots would accelerate the process of placental involution when the placenta is let in the uterine cavity, increasing the chances of uterine preservation and reducing the infectious and hemorrhagic risks in the short and medium term. The aim of this study is to confirm the feasibility and safety of the use of HIFU as a per-caesarean adjuvant treatment for management of placenta accrete let in the uterus for a conservative treatment.

Conditions

• Placenta Accreta

Interventions

Type	Name	Description
DEVICE	High Intensity Focused Ultrasound	HIFU shots will be performed on the placental tissue to produce necrotic lesions of approximately 30% of the total volume. A latency time of 2 minutes between each shot will be observed to avoid the accumulative heat effect, and to ensure optimal positioning of the treatment probe. The maximum duration of the operating time for HIFU shooting shall not exceed 60 minutes.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-09-04
• Completion: 2023-09-04
• First posted: 2019-07-01
• Last updated: 2023-11-18