Clinical trial NCT04650516: Endocare® (Single Care) in Pain-related Endometriosis
Official title: Evaluation of Pain Relief in Patients Experiencing Endometriosis-related Pain and Treated With Endocare®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Pain
Lead sponsor: Lucine
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, comparative, open-label, controlled interventional pilot study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean pain intensity 60 minutes after the beginning of treatment
timeFrame: 60 minutes after treatment
Secondary outcomes:
measure: Evaluate the pain evolution after Endocare® compared to the digital control
timeFrame: baseline (before treatment), 15 minutes, 30 minutes, 45 minutes, and 240 minutes after treatment
measure: Evaluate the pain relief after Endocare ® compared to the digital control
timeFrame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment
measure: Evaluate the maximum reduction in pain after Endocare® compared to the digital control
timeFrame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment
measure: Describe the women satisfaction toward Endocare® or the digital control
timeFrame: 240 minutes after treatment
measure: Evaluate the safety of Endocare® or the digital control
timeFrame: through study completion, at 240 minutes after treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos
state: Gironde
Study officials:
affiliation: Clinique Tivoli Ducos
name: Benjamin Merlot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merlot B, Dispersyn G, Husson Z, Chanavaz-Lacheray I, Dennis T, Greco-Vuilloud J, Fougere M, Potvin S, Cotty-Eslous M, Roman H, Marchand S. Pain Reduction With an Immersive Digital Therapeutic Tool in Women Living With Endometriosis-Related Pelvic Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Sep 21;24(9):e39531. doi: 10.2196/39531.