Feasibility of HIFU for Management of Placenta Accreta (HIFU-ACCRETA) (HIFU-ACCRETA)
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|ClinicalTrials.gov Identifier: NCT04003428|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : January 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Placenta Accreta||Device: High Intensity Focused Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perioperative Evaluation of High Intensity Focalized Ultrasound for Adjuvant Management of Placenta Accreta: a Clinical Feasibility Study|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||January 2023|
Experimental: Per-caesarean HIFU shots
Adjuvant treatment with High Intensity Focused Ultrasound (HIFU) performed the day of the scheduled childbirth, after confirmation of placenta accreta, and after fetal extraction by caesarian section.
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.
- Success of HIFU per-caesarean shots [ Time Frame: Up to 30 days after procedure ]Number of patients for whom: the probe is positioned in contact with the uterine serosa; and, one or more lesions of at least 1 cm each are visible on intraoperative ultrasound; and, total intervention time is 60 minutes maximum; and, no lesion are visible on the uterus; and, constants are maintained during the intervention; and, no related complication occurred during the intervention.
- Ultrasound characteristics of placental lesions produced over time [ Time Frame: Up to 6 months after procedure ]
- MRI characteristics of placental lesions produced over time [ Time Frame: Up to 6 months after procedure ]
- Characteristics of lesions produced by macroscopic and microscopic pathological examination of the placenta (only in case of hysterectomy) [ Time Frame: Up to 6 months after procedure ]
- Spontaneous uterine vacuity [ Time Frame: Up to 6 months after procedure ]evaluated by endovaginal ultrasound examination. This examination will be supplemented by a liquid contrast ultrasound in accordance with standard clinical practices to identify the possible presence of synechia
- Spontaneous uterine vacuity delay [ Time Frame: Up to 6 months after procedure ]measured in daytime. This is an estimate. After surgery on the uterus (e.g. hysterectomy, hysteroscopy, aspiration-curetage endo-uterin) it is considered that spontaneous uterine emptiness is not obtained.
- Occurrence of a complication (hemorrhage, infection or other) [ Time Frame: Up to 6 months after procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003428
|Contact: Cyril HUISSOUD||+33 4 72 07 29 firstname.lastname@example.org|
|Hospices Civils de Lyon - Hôpital de la Croix Rousse|
|Lyon, France, 69004|
|Contact: Cyril HUISSOUD +33 4 72 07 29 09 email@example.com|
|Principal Investigator: Cyril HUISSOUD|