Endocare® (Single Care) in Pain-related Endometriosis

NCT04650516 | Completed

• 1 other identifier: 20206-A01541-38
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Pain

Outcome Measures

Primary Outcomes (1)

• Mean pain intensity 60 minutes after the beginning of treatment

  Pain assessment evaluated with numerical rating scale (NRS): Pain assessed by 11-point numerical rating scale (NRS): 0=no pain; 10=unbearable pain

  60 minutes after treatment

Secondary Outcomes (5)

• Evaluate the pain evolution after Endocare® compared to the digital control

  baseline (before treatment), 15 minutes, 30 minutes, 45 minutes, and 240 minutes after treatment

• Evaluate the pain relief after Endocare ® compared to the digital control

  15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment

• Evaluate the maximum reduction in pain after Endocare® compared to the digital control

  15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment

• Describe the women satisfaction toward Endocare® or the digital control

  240 minutes after treatment

• Evaluate the safety of Endocare® or the digital control

  through study completion, at 240 minutes after treatment

Study Arms (2)

Endocare treatment

EXPERIMENTAL

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

Device: Virtual reality

Digital control treatment

ACTIVE COMPARATOR

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

Device: Digital control

Interventions

Virtual reality DEVICE

20 minutes treatment in virtual reality

Endocare treatment

Digital control DEVICE

20 minutes digital control movie on tablet without virtual reality

Digital control treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman ≥ 18 years old
• With a diagnosis of endometriosis
• Willing to participate in the study and having signed the informed consent form

You may not qualify if:

• Pregnant or breastfeeding woman
• 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

Sponsors & Collaborators

• Lucine: lead

Study Sites (1)

Clinique Tivoli Ducos

Bordeaux, Gironde, 33000, France

Location

Related Publications (1)

• 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.

  PMID: 36129733 DERIVED

MeSH Terms

Conditions

Endometriosis; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin Merlot, MD

  Clinique Tivoli Ducos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, comparative, open-label, controlled interventional pilot study

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 2, 2020
• Study Start: December 3, 2020
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)