EndometriosisNCT04650516
Endocare® (Single Care) in Pain-related Endometriosis
A study testing Virtual reality in people with Endometriosis and Pain, run by Lucine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Pain
- What is being tested?
- Virtual reality
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2020to 18 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pain Relief in Patients Experiencing Endometriosis-related Pain and Treated With Endocare®
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.
Read the 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
- Being tested
- Virtual reality, Digital control
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
20 minutes treatment in virtual reality
Digital controlDevice
20 minutes digital control movie on tablet without virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Endocare treatment | Experimental | Patients will receive the treatment on a dedicated virtual reality headset to display the Endocare® application, with high quality headphones Receives: 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 Receives: Device: Digital control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 minutes after treatment
Secondary outcomes (5)
Evaluate the pain evolution after Endocare® compared to the digital control
Pain assessment evaluated with numerical rating scale (NRS):
11-point numerical scale (0=no pain; 10=unbearable pain)
Measured: 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
The time to reach and maintain pain relief as assessed by the pain relief score ≥ 3
PRS is a 5-point categorical scale (0: no relief, 1: slight relief, 2: moderate relief, 3: lots of relief and 4: complete relief)
The event will be defined by the first occurrence of PRS ≥ 3
Measured: 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
The time to reach and maintain pain reduction ≥30% and ≥50% evaluated with NRS 11-point numerical scale (0=no pain; 10=unbearable pain)
Measured: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment
Describe the women satisfaction toward Endocare® or the digital control
Satisfaction after using Endocare® compared to the digital control, will be self-rated by the patient on a 7-point Likert scale:
1: extremely dissatisfied, 2: very dissatisfied, 3: rather dissatisfied, 4: neutral, 5: rather satisfied, 6: very satisfied, 7: extremely satisfied
Measured: 240 minutes after treatment
Evaluate the safety of Endocare® or the digital control
Incidence of adverse events (AE)
Measured: through study completion, at 240 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start3 Dec 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, comparative, open-label, controlled interventional pilot study
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Merlot, MD, Principal investigator, Clinique Tivoli Ducos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650516
- Sponsor's protocol ID
- 20206-A01541-38
- Status last verified
- Aug 2021
- First submitted
- 16 Nov 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36129733
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Relief in Patients Experiencing Endometriosis-related Pain and Treated With Endocare®
- ClinicalTrials.gov ID
- NCT04650516
- Acronym / sponsor ID
- 20206-A01541-38
- Conditions
- Endometriosis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- LucineIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, comparative, open-label, controlled interventional pilot study
| Arm | Type | Receives |
|---|---|---|
| Endocare treatment | Experimental | Device: Virtual realityPatients will receive the treatment on a dedicated virtual reality headset to display the Endocare® application, with high quality headphones |
| Digital control treatment | Active comparator | Device: Digital controlPatients will receive the digital control on a dedicated tablet to display the digital control, with high quality headphones |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality20 minutes treatment in virtual reality | Device | Endocare treatment |
| Digital control20 minutes digital control movie on tablet without virtual reality | Device | Digital control treatment |
Primary outcome
Mean pain intensity 60 minutes after the beginning of treatment
Time frame: 60 minutes after treatment
Pain assessment evaluated with numerical rating scale (NRS): Pain assessed by 11-point numerical rating scale (NRS): 0=no pain; 10=unbearable pain
5 secondary outcomes
Evaluate the pain evolution after Endocare® compared to the digital control
Time frame: 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
Time frame: 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
Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment
Describe the women satisfaction toward Endocare® or the digital control
Time frame: 240 minutes after treatment
Evaluate the safety of Endocare® or the digital control
Time frame: through study completion, at 240 minutes after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 36129733Merlot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Merlot, MD principal investigator
Clinique Tivoli Ducos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Endometriosis and Pain, run by Lucine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain intensity 60 minutes after the beginning of treatment (time frame: 60 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.