Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-28 @ 8:49 AM
Study NCT ID:
NCT05172492
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity change', 'timeFrame': 'Time points are before treatment (Time 0) and one hour after treatment (Time 1) during t five days (Day 1, Day 2, Day 3, Day 4, Day 5)', 'description': 'The mean change in pain intensity assessed by a numeric rating scale (pain intensity numerical scale) between the pre-treatment measurement and one hour after the use of Endocare treatment, compared to the digital control during the five days of treatment.The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).'}], 'secondaryOutcomes': [{'measure': 'Change in pain intensity', 'timeFrame': 'at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5)', 'description': 'Change in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).'}, {'measure': 'Change in pain relief', 'timeFrame': 'At 1 hour (Time 1), 2 hours (Time 2) and 3 hours (Time 3) after treatment during the 5 days of treatment (Day 1 to Day 5)', 'description': 'Change in pain relief assessed by Likert pain relief scale. Its a 5-point categorical scale (0: no relief, 1: slight relief, 2: moderate relief, 3: lots of relief and 4: complete relief)'}, {'measure': 'Weighted average change in pain intensity', 'timeFrame': 'from pre-treatment (Time 0) to 2 hours (Time 2) and 3 hours (Time 3) post-treatment during the 5 days of treatment (Day 1 to Day 5)', 'description': 'Weighted average change (based on number of treatments Endocare or control uses) in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).'}, {'measure': 'Change in stress value', 'timeFrame': 'at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)', 'description': "Change in stress assessed by Visual Analogue Scale (VAS). Visual Analogue Scale (VAS) consists of a small unmarked 100 mm ruler with ends labelled 'none' and 'as bad as possible'."}, {'measure': 'Change in fatigue value', 'timeFrame': 'at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)', 'description': 'Change in stress assessed by Visual Analogue Scale (VAS) and fatigue assessed by Pichot Scale. The Pichot scale evaluates 8 fatigue items ranging from 0 to 4 (0: not at all; 1: a little; 2: moderately; 3: a lot; 4: extremely)'}, {'measure': 'Change in endometriosis-related quality of life', 'timeFrame': 'At inclusion visit Day 0 and at through study completion (Day 6), an average of one week', 'description': 'Change in endometriosis-related quality of life assessed by Endometriosis Health Profile (EHP-5). The EHP-5 consists of 11 items ranging from "never" to "always"'}, {'measure': 'Assessment of the predictive value of dramatization and catastrophizing thoughts', 'timeFrame': 'At the inclusion visit Day 0', 'description': 'Assessment of the predictive value of dramatization and catastrophizing thoughts assessed by Patient catastrophizing scale (PCS) coonsisting of 13 items ranging from 0 to 4 (0= not at all; 1= to a slight degree; 2= to a moderate degree; 3= to a great degree; 4 = all the time).'}, {'measure': 'Pain relief treatments', 'timeFrame': 'during the five days of treatment (Day 1 to Day 5) at bedtime', 'description': 'Number, frequency and dosage of pain relief treatments assessed by patient diary'}, {'measure': 'Assessment of satisfaction', 'timeFrame': 'through study completion (Day 6), an average of one week', 'description': 'Assessment of satisfaction by Likert scale. It is a 7-point Likert scale (1: extremely dissatisfied, 2: very dissatisfied, 3: dissatisfied, 4: neutral, 5: satisfied, 6: very satisfied, 7: extremely satisfied).'}, {'measure': 'Assessment of Clinical Global Impression of Improvement', 'timeFrame': 'through study completion (Day 6), an average of one week', 'description': 'Assessment of Clinical Global Impression of Improvement by CGI scale. It is a 7-point scale (1=very much improved; 7=very much worse)'}, {'measure': 'Incidence of adverse events and treatment adherence', 'timeFrame': 'during the five days of treatment (Day 1 to Day 5)', 'description': 'Incidence of adverse events and treatment adherence collected by patients diary and phone'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Chronic Pain', 'Pelvic Pain']}, 'referencesModule': {'references': [{'pmid': '37260160', 'type': 'DERIVED', 'citation': 'Merlot B, Elie V, Perigord A, Husson Z, Jubert A, Chanavaz-Lacheray I, Dennis T, Cotty-Eslous M, Roman H. Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial. J Med Internet Res. 2023 Jun 28;25:e47869. doi: 10.2196/47869.'}]}, 'descriptionModule': {'briefSummary': "Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life.\n\nApart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.\n\nEndocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.\n\nMoreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.\n\nThe effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women over 18 years of age with diagnosed endometriosis (histology, imaging, clinical symptomatology) and/or adenomyosis.\n* Women with at least 2 consecutive days per month of endometriosis-related pelvic-perineal pain of moderate to severe intensity (NS ≥ 4):\n\n * Women without amenorrhea: pain around the onset of menstruation.\n * Women with amenorrhea: most intense pain of the month.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Women participating, or who have participated, in a clinical interventional study within 30 days prior to inclusion.\n* Women with severe visual, auditory or cognitive impairment, color blindness, photosensitivity, epilepsy or motion sickness.\n* Women whose pain is occasional and not present at each menstrual period.\n* Women who have previously received virtual reality treatments.\n* Women under judicial protection, guardianship, curatorship, protective mandate.'}, 'identificationModule': {'nctId': 'NCT05172492', 'briefTitle': 'Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lucine'}, 'officialTitle': 'Efficacy of Endocare Treatment at Home on Pain in Women With Chronic Pelvic-perineal Pain Related to Endometriosis. EndoHome.', 'orgStudyIdInfo': {'id': '2021-A02358-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endocare', 'interventionNames': ['Device: Endocare']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digital control', 'interventionNames': ['Device: Digital control']}], 'interventions': [{'name': 'Endocare', 'type': 'DEVICE', 'description': 'Endocare will be administred through a virtual reality headseat used one to twice a day.', 'armGroupLabels': ['Endocare']}, {'name': 'Digital control', 'type': 'DEVICE', 'description': 'Digital control will be administred through a virtual reality headseat used one to twice a day.', 'armGroupLabels': ['Digital control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'state': 'Gironde', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Merlot, MD', 'role': 'CONTACT', 'email': 'merlot.benjamin@gmail.com', 'phone': '+33650139254'}], 'facility': 'Clinique Tivoli Ducos', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lucine', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biotrial', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}