Lymphedema of GenitaliaOLYMPYNCT04602559
Exploratory Study : to Evaluate the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema
A study testing MOBIDERM Panty group in people with Lymphedema of Genitalia, run by Thuasne at 3 sites in France.
Trial summary
Lymphedema (LO) is a chronic and disabling condition that affects quality of life. This pathology has a physical, psychological, social and professional impact. Pelvic or genital lymphedema (LP/LG) is the result of a dysfunction of the lymphatic system in the genital area that can occur following surgery, radiation… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lymphedema of Genitalia
- What is being tested?
- MOBIDERM Panty group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Dec 2020to 9 Jul 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary or secondary pelvic or genital lymphedema of stage II ou III according to the criteria defined by the International Society of Lymphology.
- Patient with discomfort related to lymphedema
- Presence of the Stemmer's sign if applicable
- Patient with a morphology compatible with the 6 sizes of the MOBIDERM Panty (Minimum and maximum pelvic circumference: 88 and 129 cm respectively)
- Patient who gave signed, informed, voluntary consent prior to any intervention in the study
- Patient affiliated to the General regime of the Social Security or covered by a similar health insurance system
Who cannot join
- Pregnant woman or woman of childbearing age without contraception
- Patient with surgery of the small pelvis or genitals performed within the last 3 months prior to inclusion or any surgery scheduled during the study period
- Patient with hydrocoele
- Patient who had intensive reduction therapy for lower limb lymphedema within the last month
- Patient with a contraindication to compression, such as untreated infection, skin irritation, recent thrombosis (< 3 months), obliterative arterial disease of the lower limbs with a systolic pressure index < 0.6, phlegmatia coerulea dolens (painful blue phlebitis with arterial compression) in the thigh area
- Patient with decompensated heart failure
Show all 14Show fewer
- Patient with a known allergy to the components used in the Panty
- Patient with untreated or escaped cancer
- Patient with a postectomy within the last 3 months prior to inclusion
- Patient with significant edema localized only to the labia minora
- Patient with psychiatric, psychological or neurological disorders that are incompatible with proper follow-up of a clinical study
- Patient participating in other research involving the human person impacting the main judgement criteria
- Patient cannot be followed for 12 weeks
- Vulnerable patient according to article L1121-6 of the French public health code, or subject being the object of a legal protective measure or enable to express his consent freely
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
Montpellier, 34295
Hôpital Cognacq-Jay - unité de lymphologie
Paris, 75015
CHU TOULOUSE - service médecine vasculaire
Toulouse
About this study
Official title: Exploratory Study to Evaluate the Clinical Benefits of Wearing the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema : OLYMPY Study
Lymphedema (LO) is a chronic and disabling condition that affects quality of life. This pathology has a physical, psychological, social and professional impact. Pelvic or genital lymphedema (LP/LG) is the result of a dysfunction of the lymphatic system in the genital area that can occur following surgery, radiation therapy, tumor, infections affecting the inguinal lymph nodes or related lymphatic pathways (secondary LP/LG). Urogenital cancers are the major cause of secondary LP/LG. It is difficult to have an accurate estimate of the prevalence of LP/LG. LP/LG can be painful, the edema very bulky and disharmonious. The patient is facing with significant physical and psychological difficulties. The volume of the lymphedema can be important, causing discomfort, rubbing when walking or during physical activities, disrupting daily life and may constitute a major handicap.
Read the detailed description
Currently, there is no reference treatment which is validated for these lymphedemas, and few recommendations from the competent authorities or learned societies are available. There is no solution available on the market which covers all the needs and expectations of patients and healthcare professionals.
The Panty MOBIDERM is a standard pelvic compressive orthosis that should promote lymphatic drainage, then reduce the volume of edema, and contributing to an overall improvement in the patients' quality of life.
- Conditions
- Lymphedema of Genitalia
- Being tested
- MOBIDERM Panty group
- Keywords
- genital lymphedema, panty, compression, volume reduction, quality of life, pelvic lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBIDERM Panty groupDevice
In the MOBIDERM Panty group, patients wear the MOBIDERM Panty during day and night for 3 months with the possibility to add the PAD.
The protocol includes 3 visits.
Visit 1 at day 0, corresponding to the inclusion visit, includes device delivery and some clinical evaluations (clinical examination, characteristics of lymphedema, self questionnaires, pain assessment, perimeter data).
Visit 2 at 30 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).
Visit 3 at 90 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).
| Study group | Role | What they receive |
|---|---|---|
| MOBIDERM Panty group | Experimental | MOBIDERM Panty group :
All patients will wear the Panty MOBIDERM device for 12 weeks, day and night recommended. A removable pad is also recommended to be worn additionnaly to the panty. Receives: Device: MOBIDERM Panty group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
The patient's impression of overall change is measured by the Patient's opinion on Global Impression of Change questionnaire. The scale has 7 levels of response :
"no change or condition has got worse" that is the worst outcome (= 1 point) "almost the same, hardly any change at all" (= 2 points); "a little better , but no noticeable change" (= 3 points); "somewhat better, but the change has not made any real difference" (= 4 points); "moderately better, and a slight but noticeable change" (= 5 points); "better, and a definite improvement that has made a real and worthwhile difference (=6 points) "A great deal better, and a considerable improvement that has made all the diiference" (=7 points) The highest score corresponds to the most improvement in quality of life.
Measured: 90 days
Secondary outcomes (12)
Quality of life (QoL): Lymphedema Quality of Life Inventory (LyQLI) self-questionnaire
The evolution of quality of life is measured by the lymphedema Quality of life Inventory self-questionnaire. This tool is designed as a patient-completed questionnaire.
It comprises 45 items. Forty-one items are divided into three multi-item domains: physical (12 questions), psychosocial (16 questions), and practical (13 questions).
For each item, the impact of lymphedema over the last 4 weeks is assessed on a 4-point Likert scale (0: None, 1: A little bit, 2: Somewhat, 3: A lot). Scores are presented as the mean for each domain, ranging from 0.0 to 3.0. A higher score indicates lower QoL. The questionnaire also includes four global questions, of which item 44 assesses the overall experience of lymphedema and item 45 the overall quality of life, both on a 4-point Likert scale ranging from 0:Very bad to 3: Very good. A higher score indicates higher QoL.
Measured: day : 0, 30, 90
Swelling, tension, discomfort and feeling of heaviness :Visual Analog Scale (VAS)
Evolution of swelling, tension, discomfort, feeling of heaviness are measured by a visual analog scale : 0 corresponds to no discomfort/no problem (better outcome) and 10 to maximum discomfort/maximum problem (worst outcome)
Measured: day : 0, 30, 90
Impact of lymphedema on sexual life : Visual Analog Scale (VAS)
The impact of lymphedema on patients sexual life is measured by a visual analog scale : 0 corresponds to no discomfort (better outcome) and 10 to maximum discomfort preventing sexual relation (worst outcome)
Measured: day : 0, 30, 90
Pain : Visual Analog Scale (VAS)
Evolution of pain is measured by VAS : 0 corresponds to no pain and 10 to the maximum pain.
Measured: day : 0, 30, 90
Sleep quality : Jenkins self-questionnaire
The evolution of sleep quality is measured by Jenkins self-questionnaire. This scale is composed of four questions about the quality of sleep.
Each answer is scored from 0 to 5 (0=none; 1= 1-3 days; 2 = 4-7 days; 3 = 8-14 days; 4 = 15-21 days; 5 = 22-31 days) A higher score corresponds to a bad quality of sleep.
Measured: day : 0, 30, 90
Doctors' opinion on the change of patient's health condition (Clinical Global Impression -Improvement)
Doctors' opinion on the change of patient's health condition due to lymphedema is measured by the Clinical Global Impression - Improvement questionnaire. The scale has 7 levels of answer from "very strongly improved" which is the better outcome (= 1 point) to "very strongly aggravated" which is the worst outcome (= 7 points) .Intermediate levels are: " Significantly improved "(= 2 points) ; " Slightly improved " (= 3 points) ; " No improvement " (=4 points) ; " Slightly worsen " (=5 points) ; " Seriously worsen" ( = 6 points).
The highest score corresponds to the most impairment in quality of life.
Measured: day : 30, 90
Characteristic of pelvic lymphedema : Genital Lymphedema Score (GLS)
The evolution of pelvic lymphedema characteristics is measured by GLS questionnaire including different fields (feeling of heaviness, feeling of tension, swelling, urinary disorders, lymphatic papillomatosis, genital lymphorrhea), and by taking pictures.
(0= absence of the symptom,1 or 2 = presence of the symptom)
Measured: day : 0, 30, 90
Pelvic/genital lymphedema perimetry for men only : Whitaker tool
The evolution of the pelvic/genital lymphedema is measured by perimetric measurements according to the Whitaker tool :
Measure A: middle of the scrotum Measure B: scrotal neck size Measure C: length of the scrotum
Measured: day : 0, 30, 90
Day and NIght Compliance to treatment
Compliance to treatment is reported by the physician in the electronic Case Report Forms (eCRF) according to the patient diary. The compliance is measured by calculating the number of days and nights corresponding to a wearing of the device The average wearing time is : Full day/night, >50% of the day/night,<50% of the day/night, not at all
Measured: day : 30,90
Satisfaction about the device: specific self questionnaire
Patient's and doctor's satisfaction with regards to MOBIDERM Panty by a satisfaction questionnaire. This questionnaire is focused on the product positioning and the comfort.
These are qualitative variables; there is no score.
Measured: Day : 30
Safety: Adverse Device Effects
Number and type of serious and non-serious Adverse Device Effects (ADE) are reported all along the study.
Measured: day : 0, 30, 90
Quality of life (QoL): EQ-5D-5L questionnaire
The evolution of quality of life is measured by the EQ-5D-5L questionnaire. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (Level 1 is coded as a '1'), slight problems (Level 2 is coded as a '2'), moderate problems (Level 3 is coded as a '3'), severe problems (Level 4 is coded as a '4'), and extreme problems (Level 5 is coded as a '5'). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS is measured by VAS : 100 corresponds to the best health and 0 to the the worst health.
Measured: day : 0, 30, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start3 Dec 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of GenitaliaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multicenter, interventional, open-label, prospective exploratory study in a population of patients with primary or secondary pelvic and/or genital lymphedema
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SANDRINE MESTRE, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602559
- Sponsor's protocol ID
- EC31
- Other IDs
- ANSM
- Acronym
- OLYMPY
- Status last verified
- Jan 2022
- First submitted
- 20 Oct 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garaffa G, Christopher N, Ralph DJ. The management of genital lymphoedema. BJU Int. 2008 Aug;102(4):480-4. doi: 10.1111/j.1464-410X.2008.07559.x. Epub 2008 Mar 5.
PubMed 18325055Facio MF, Spessoto LC, Gatti M, Ferraz Arruda PF, Ferraz Arruda JG, Antoniassi TS, Bogdan AP, Godoy MF, Godoy JM, Facio FN Jr. Clinical Treatment of Penile Fibrosis After Penoscrotal Lymphedema. Urol Case Rep. 2017 Jan 5;11:14-16. doi: 10.1016/j.eucr.2016.12.001. eCollection 2017 Feb.
PubMed 28083477Shim TN, Doiron PR, Francis N, Minhas S, Muneer A, Hawkins D, Dinneen M, Bunker CB. Penile lymphoedema: approach to investigation and management. Clin Exp Dermatol. 2019 Jan;44(1):20-31. doi: 10.1111/ced.13609. Epub 2018 Jul 15.
PubMed 30009576Mestre S, Vignes S, Malloizel-Delaunay J, Abba S, Villet S, Picolet A, Vicaut E, Quere I. Positive Impact of a New Compressive Garment in Patients with Genital Lymphedema: OLYMPY Study. Lymphat Res Biol. 2024 Apr;22(2):138-146. doi: 10.1089/lrb.2023.0055. Epub 2024 Apr 2.
PubMed 38563697
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Clinical Benefits of Wearing the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema : OLYMPY Study
- ClinicalTrials.gov ID
- NCT04602559
- Acronym / sponsor ID
- OLYMPY / EC31
- Conditions
- Lymphedema of Genitalia
- Keywords
- genital lymphedema, panty, compression, volume reduction, quality of life, pelvic lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 26 Oct 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.
Lymphedema (LO) is a chronic and disabling condition that affects quality of life. This pathology has a physical, psychological, social and professional impact. Pelvic or genital lymphedema (LP/LG) is the result of a dysfunction of the lymphatic system in the genital area that can occur following surgery, radiation therapy, tumor, infections affecting the inguinal lymph nodes or related lymphatic pathways (secondary LP/LG). Urogenital cancers are the major cause of secondary LP/LG. It is difficult to have an accurate estimate of the prevalence of LP/LG. LP/LG can be painful, the edema very bulky and disharmonious. The patient is facing with significant physical and psychological difficulties. The volume of the lymphedema can be important, causing discomfort, rubbing when walking or during physical activities, disrupting daily life and may constitute a major handicap.
Detailed description
Currently, there is no reference treatment which is validated for these lymphedemas, and few recommendations from the competent authorities or learned societies are available. There is no solution available on the market which covers all the needs and expectations of patients and healthcare professionals.
The Panty MOBIDERM is a standard pelvic compressive orthosis that should promote lymphatic drainage, then reduce the volume of edema, and contributing to an overall improvement in the patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multicenter, interventional, open-label, prospective exploratory study in a population of patients with primary or secondary pelvic and/or genital lymphedema
| Arm | Type | Receives |
|---|---|---|
| MOBIDERM Panty group | Experimental | Device: MOBIDERM Panty groupMOBIDERM Panty group : All patients will wear the Panty MOBIDERM device for 12 weeks, day and night recommended. A removable pad is also recommended to be worn additionnaly to the panty. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Primary or secondary pelvic or genital lymphedema of stage II ou III according to the criteria defined by the International Society of Lymphology.
- Patient with discomfort related to lymphedema
- Presence of the Stemmer's sign if applicable
- Patient with a morphology compatible with the 6 sizes of the MOBIDERM Panty (Minimum and maximum pelvic circumference: 88 and 129 cm respectively)
- Patient who gave signed, informed, voluntary consent prior to any intervention in the study
Key exclusion criteria (14 listed)
- Pregnant woman or woman of childbearing age without contraception
- Patient with surgery of the small pelvis or genitals performed within the last 3 months prior to inclusion or any surgery scheduled during the study period
- Patient with hydrocoele
- Patient who had intensive reduction therapy for lower limb lymphedema within the last month
- Patient with a contraindication to compression, such as untreated infection, skin irritation, recent thrombosis (< 3 months), obliterative arterial disease of the lower limbs with a systolic pressure index < 0.6, phlegmatia coerulea dolens (painful blue phlebitis with arterial compression) in the thigh area
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 |
|---|---|---|
| MOBIDERM Panty groupIn the MOBIDERM Panty group, patients wear the MOBIDERM Panty during day and night for 3 months with the possibility to add the PAD. The protocol includes 3 visits. Visit 1 at day 0, corresponding to the inclusion visit, includes device delivery and some clinical evaluations (clinical examination, characteristics of lymphedema, self questionnaires, pain assessment, perimeter data). Visit 2 at 30 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance). Visit 3 at 90 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance). | Device | MOBIDERM Panty group |
Primary outcome
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
Time frame: 90 days
The patient's impression of overall change is measured by the Patient's opinion on Global Impression of Change questionnaire. The scale has 7 levels of response : "no change or condition has got worse" that is the worst outcome (= 1 point) "almost the same, hardly any change at all" (= 2 points); "a little better , but no noticeable change" (= 3 points); "somewhat better, but the change has not made any real difference" (= 4 points); "moderately better, and a slight but noticeable change" (= 5 points); "better, and a definite improvement that has made a real and worthwhile difference (=6 points) "A great deal better, and a considerable improvement that has made all the diiference" (=7 points) The highest score corresponds to the most improvement in quality of life.
12 secondary outcomes
Quality of life (QoL): Lymphedema Quality of Life Inventory (LyQLI) self-questionnaire
Time frame: day : 0, 30, 90
Swelling, tension, discomfort and feeling of heaviness :Visual Analog Scale (VAS)
Time frame: day : 0, 30, 90
Impact of lymphedema on sexual life : Visual Analog Scale (VAS)
Time frame: day : 0, 30, 90
Pain : Visual Analog Scale (VAS)
Time frame: day : 0, 30, 90
Sleep quality : Jenkins self-questionnaire
Time frame: day : 0, 30, 90
Doctors' opinion on the change of patient's health condition (Clinical Global Impression -Improvement)
Time frame: day : 30, 90
Characteristic of pelvic lymphedema : Genital Lymphedema Score (GLS)
Time frame: day : 0, 30, 90
Pelvic/genital lymphedema perimetry for men only : Whitaker tool
Time frame: day : 0, 30, 90
Day and NIght Compliance to treatment
Time frame: day : 30,90
Satisfaction about the device: specific self questionnaire
Time frame: Day : 30
Safety: Adverse Device Effects
Time frame: day : 0, 30, 90
Quality of life (QoL): EQ-5D-5L questionnaire
Time frame: day : 0, 30, 90
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 26 Jan 2022.
- Background: PubMed 18325055Garaffa G, Christopher N, Ralph DJ. The management of genital lymphoedema. BJU Int. 2008 Aug;102(4):480-4. doi: 10.1111/j.1464-410X.2008.07559.x. Epub 2008 Mar 5.
- Background: PubMed 28083477Facio MF, Spessoto LC, Gatti M, Ferraz Arruda PF, Ferraz Arruda JG, Antoniassi TS, Bogdan AP, Godoy MF, Godoy JM, Facio FN Jr. Clinical Treatment of Penile Fibrosis After Penoscrotal Lymphedema. Urol Case Rep. 2017 Jan 5;11:14-16. doi: 10.1016/j.eucr.2016.12.001. eCollection 2017 Feb.
- Background: PubMed 30009576Shim TN, Doiron PR, Francis N, Minhas S, Muneer A, Hawkins D, Dinneen M, Bunker CB. Penile lymphoedema: approach to investigation and management. Clin Exp Dermatol. 2019 Jan;44(1):20-31. doi: 10.1111/ced.13609. Epub 2018 Jul 15.
- Derived from this study: PubMed 38563697Mestre S, Vignes S, Malloizel-Delaunay J, Abba S, Villet S, Picolet A, Vicaut E, Quere I. Positive Impact of a New Compressive Garment in Patients with Genital Lymphedema: OLYMPY Study. Lymphat Res Biol. 2024 Apr;22(2):138-146. doi: 10.1089/lrb.2023.0055. Epub 2024 Apr 2.
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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.
SANDRINE MESTRE, MD PhD principal investigator
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOBIDERM Panty group in people with Lymphedema of Genitalia, run by Thuasne at 3 sites 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 6 inclusion and 14 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C) (time frame: 90 days). 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 NCT04602559, which also lists 4 linked publications.
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 26 Jan 2022.