Endocare® (Single Care) in Pain-related Endometriosis

NCT ID: NCT04650516

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2021-05-18

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.

Conditions

Endometriosis; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endocare treatment

Patients will receive the treatment on a dedicated virtual reality headset to display the Endocare® application, with high quality headphones

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: DEVICE

20 minutes treatment in virtual reality

Digital control treatment

Patients will receive the digital control on a dedicated tablet to display the digital control, with high quality headphones

Group Type: ACTIVE_COMPARATOR

Digital control

Intervention Type: DEVICE

20 minutes digital control movie on tablet without virtual reality

Interventions

Virtual reality

20 minutes treatment in virtual reality

Intervention Type: DEVICE

Digital control

20 minutes digital control movie on tablet without virtual reality

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lucine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Merlot, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Tivoli Ducos

Locations

Clinique Tivoli Ducos

Bordeaux, Gironde, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36129733 (View on PubMed)

Other Identifiers

20206-A01541-38

Identifier Type: -

Identifier Source: org_study_id