Efficacy of Cryoablation of Abdominal Wall Endometriosis (CRYOENDOMET)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Nodule; Endometriosis

Treatments: Procedure: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03627676

2017-A02409-44 (Other Identifier)

P160802J

Details and patient eligibility

About

The aim of this study is to evaluate for the first time prospectively the efficacy on the symptoms and the tolerance of percutaneous cryoablation performed under radiological guidance of endometriosis of the abdominal wall in alternative to surgery after validation in multidisciplinary meeting.

Full description

Design of the study :

Non-comparative, non-randomized monocentric phase II trial designed as a two-staged Simon minimax plan.

Inclusions will be suspended at the end of the first stage. Statistical stopping rules are detailed in the justification of the number of patients required.

Inclusion: Patients will be included after validation in multidisciplinary consultation by the interventional radiologist in charge of the patient.

Follow-up: Only the cryoablation procedure is performed as an alternative to surgery, the usual follow-up of these patients will be maintained (1 consultation / 3 months, 1 MRI every 6 months). Additional consultations on D7 and M1 will be conducted by phone (symptoms and pain history only).

Device(s) under investigation The Endocare® Cryocare® Systems consist of a compact, easy-to-operate console and associated accessories that include Endocare® cryoprobes to deliver cold temperatures to the therapeutic tissue and Endocare® TempProbe® devices to monitor temperatures in the surrounding tissue. The Cryocare® Systems are intended for use in open, minimally invasive procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, pulmonary surgery and thoracic surgery.

The systems are designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

CE Mark; Classe IIa

Expected benefits for the participants and for society This study has a direct individual benefit because of the proposed curative treatment by cryoablation as an alternative to other therapeutic modalities. For the society, the minimally invasive cryoablation may reduce the hospitalization stay and the complication's rate compare to the reference standard (surgery).

Enrollment: 17 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥18 years,

• Initial radiological diagnosis of endometriosis of the abdominal wall, radiologically proven by MRI (or Doppler-ultrasound or CT-scan) with or without contrast injection,

• Symptomatic nodule (pain),

• Patient in at least one of the following situations:

  • Failure of previous treatments: recurrence of symptoms (pain) after medical therapies following the Haute Autorité de Santé (HAS) recommendations and / or prior surgery,
  • Or first-line or second-line medical therapies following the HAS recommendations considered as potentially non effective locally in multidisciplinary consultation meeting, or contraindicated or refused by patient,
  • Or surgery considered as potentially non effective locally or as a potential cause of adverse effects and morbidity because too devastating, in multidisciplinary consultation meeting,

• Cryoablation technically feasible after discussion in multidisciplinary consultation meeting:

  • localization at a distance of 5 mm from the skin (risk of skin lesion if the ice ball is at less than 5 mm from the skin) and from major nervous structures (risk of sideration),
  • 3 nodules maximum
  • nodule size up to 5 cm (<5 cm) in the largest diameter

• Absence of contraindications to general anesthesia if applicable,

• Effective contraception during participation in the study.

• Informed consent signed,

• Patient affiliated to a social security.

Exclusion criteria

• Pregnant woman,
• Uncontrolled coagulation disorders (TP <50%, TCA> 1.5x control) or anticoagulant therapy (blood sample prescribed at the inclusion and results verified at D0),
• Abnormalities of the hemogram: platelets <90000/mm3 (blood sample prescribed at the inclusion and results verified at D0),
• Documented infectious disease,
• Patient included in another interventional study,
• Impossibility to submit to the medical follow-up for geographical, social or psychological reasons,
• Patients deprived of liberty or subject to a legal protection measure or unable to express their consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

Intervention

Experimental group

Treatment:

Procedure: Cryoablation