Endocare® (Single Care) in Pain-related Endometriosis

Lucine

Status

Completed

Conditions

Endometriosis

Pain

Treatments

Device: Digital control

Device: Virtual reality

Study type

Interventional

Funder types

Industry

Identifiers

NCT04650516

20206-A01541-38

Details and patient eligibility

About

Endocare® treatment is a stand-alone software medical device, which is composed of a mobile application and an accessory VR headset, intended to mitigate the pain for patients prone to endometriosis.

Full description

Mitigation of pain is realized through sequences of treatments via audio and visual stimulations.

The Endocare® treatment's main functionality, which addressed the intended purpose, is conducting sequences for treatment to mitigate the pain sensed by the patient.

The software will allow mitigating the sensed pain through 3D Virtual Reality via sequences of environments. The software will emit through sequences of 3D environments, auditory and visual stimulations.

The medical device is a CE marked Class I device. Women suffering from endometriosis present recurrent pelvic pain impairing their quality of life. The endometriosis-related pain has pejorative repercussions on sexual, family and professional life. Currently, the physician armamentarium is limited to analgesics and non-steroid anti-inflammatory drugs to treat endometriosis-related pain. Endocare® treatment intends to relieve pain thanks to its action on central nervous system. This study will describe the evolution of pain in patients experiencing endometriosis-related pain after a single treatment of Endocare® or a digital control.

The use of a digital control as a comparator is the only way to show a specific effect of the Endocare® treatment. Therefore, a digital control displaying visual and auditive sequences with no expected effect will be used for the study. This digital control, for which only a placebo effect may occur, will be displayed on a tablet instead of VR (Colloca et al., 2020).

The main analysis will be performed on an intent-to-treat basis. The statistical analysis will be performed using the SAS 9.4 (or higher) software (SAS Institute, Cary, NC, USA).

Continuous variables will be described by the number of observations, mean, standard deviation, minimum, maximum and median. Categorical variables will be described by the number and percentage of each modality. Percentages will be calculated on the number of observed data.

Enrollment

45 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Woman ≥ 18 years old
With a diagnosis of endometriosis
Willing to participate in the study and having signed the informed consent form
Suffering from a moderate-to-severe endometriosis-related pain ≥ 4 on numerical rating scale (NRS) at the time of inclusion

Exclusion criteria

Pregnant or breastfeeding woman
Woman having consumed painkillers within 8h prior inclusion
Woman participating in an interventional study or having participated in an interventional study within the 30 days before enrolment
Contraindication to Endocare® or digital control: patients with severe visual, hearing and/or cognitive impairments, patients with colour blindness, patients who are photo-sensitive or suffering from epilepsy or motion sickness
Woman being an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator