Efficacy of Cryoablation of Abdominal Wall Endometriosis (CRYOENDOMET)
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|ClinicalTrials.gov Identifier: NCT03627676|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nodule Endometriosis||Procedure: Cryoablation||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial|
|Actual Study Start Date :||February 8, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
Two percutaneous cryoprobes would be used for all patients. The 17-Gauge cryoprobes is introduced into the masses under US guidance. Mean distance to the skin has to be 5mm at least. Although US guidance is used, a non-enhanced CT scan may be used to assess the position of the cryoprobes before ablation, and to obtain a baseline examination in order to avoid thermal injuries to adjacent tissues such as the bowel during the ice growth. No ice extension to the skin has to be observed during cycles assessed by real-time US monitoring. Each cryoablation procedure involves 3 successive cycles: 10 minutes freeze with Argon gas, followed by 9 minutes passive and 1 minute active thawing with Helium gas, followed by a second 7 minutes freeze. The ice covered the entire targeted lesion on the short axes is visualize by US or CT-scan performed at the end of the three cycles or after repositioning. At the end of the cryoablation procedures, the probes are removed through active thawing.
- To evaluate the clinical efficacy at 6 months of cryoablation on the pain initially presented by the patients, pain being the principal reason of consultation. [ Time Frame: 6 months ]
The post-therapeutic pain is quantified by Numerical Scale (NS) at 6 months of cryoablation.
Clinical success is defined as a complete response (NS= 0) or a reduction of at least 50% in the NS score at baseline.
- Complications rate at 6 months of cryoablation [ Time Frame: 6 months ]The occurrence of all complications of cryoablation between the intervention and the end of follow-up, according to the classification of the NCI-CTCAE toxicity scale, will be considered.
- The rate of full hospitalization after cryoablation when an outpatient basis was planned [ Time Frame: 6 months ]Proportion of hospitalisation in woman with outpatient stay initialy planned.
- The length of hospitalization (number of days) when a full hospitalization was planned [ Time Frame: 6 months ]Total duration of hospitalization according to the type of initial stay (outpatient or hospitalization) planned, defined as the time (number of days) from the date of entry and the date of departure of the initial intervention + delays (in days) between entry date for a new intervention and date of exit within the limit of 6 Months of follow-up.
- The evolution of pain (1) [ Time Frame: baseline ]The evolution of the pain assessed at inclusion (D-90-D-3 = inclusion) by a Numerical scale.
- The evolution of pain (2) [ Time Frame: hour 0 ]The evolution of the pain assessed immediately before (H0) cryoablation by a Numerical scale.
- The evolution of pain (3) [ Time Frame: 6 hours post-intervention ]The evolution of the pain assessed after cryoablation (H6) by a Numerical scale.
- The evolution of pain (4) [ Time Frame: 7 days post-intervention ]The evolution of the pain assessed at D7 by a Numerical scale.
- The evolution of pain (5) [ Time Frame: 1 month post-intervention ]The evolution of the pain assessed at 1 month by a Numerical scale.
- The evolution of pain (6) [ Time Frame: 3 months post-intervention ]The evolution of the pain assessed at 3 months by a Numerical scale.
- The evolution of pain (7) [ Time Frame: 6 months post-intervention ]The evolution of the pain assessed at 6 months by a Numerical scale.
- The evolution of quality of life [ Time Frame: baseline, 3 and 6 months post-intervention ]The evolution of the quality of life by the EHP-5 self-questionnaire. The quality of life is assessed at inclusion and at 3 and 6 months of cryoablation.
- The success rate of the technique of cryoablation at 6 months [ Time Frame: 6 months ]The technical success at 6 months is defined by a reduction in volume of endometriosis nodule of at least 2/3 of the initial volume on MRI (complete or partial response on MRI according to the RECIST criteria) at 6 months of treatment. Success rate will be assessed at the level of the treated nodule.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627676
|Contact: François Cornelis, Professor||+33 1 56 01 68 email@example.com|
|Paris, France, 75970|
|Contact: François Cornelis, Professor +33 1 56 01 68 87 firstname.lastname@example.org|
|Principal Investigator:||François Cornelis, Professor||Assistance Publique - Hôpitaux de Paris|