Product Use IssueNCT04181580
Feasibility Study Focusing on Fit of Made-to-measure Compression Garments in Healthy Subjects
A study testing Made-to-measure compression garment in people with Product Use Issue, run by BSN Medical GmbH at 1 site in Germany.
Trial summary
Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Product Use Issue
- What is being tested?
- Made-to-measure compression garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2019to 13 Dec 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men, women or diverse
- Full legal competence
- Age between 18 and 70 years
- Capability to understand the subject information and to provide conscious informed consent
- All female or diverse subjects of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a Pearl-Index of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner for at least 4 weeks
- Willingness to conduct a urine pregnancy test for all females or potentially childbearing diverse subjects
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- Capability and willingness to follow protocol requirements
- Signed informed consent for study participation and data protection regulations
- Body mass index (BMI) >23 kg/m² and ≤ 40 kg/m²
Who cannot join
- Circumference of the largest circumference of the upper leg >80 cm (measured in the upright position)
- Shape distortions
- Diagnosed lymphedema of the upper and/or lower extremities
- Diagnosed lipedema of upper and/or lower extremities
- Diagnosed indication for therapy with flat-knitted compression garments
- Alcohol abuse as reported by subject and/ or suspected by investigator
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- Drug abuse as reported by subject and/ or suspected by investigator
- Allergy or sensitivity to one or more components of the investigational devices, as far as reported by the subject
- Circumference of the largest circumference of the upper leg >80 cm (measured in the upright position)
- Shape distortions
- Diagnosed lymphedema of the upper and/or lower extremities
- Diagnosed lipedema of upper and/or lower extremities
- Diagnosed indication for therapy with flat-knitted compression garments
- Alcohol abuse as reported by subject and/ or suspected by investigator
- Drug abuse as reported by subject and/ or suspected by investigator
- Allergy or sensitivity to one or more components of the investigational devices, as far as reported by the subject
- Pregnancy or breastfeeding
- Diagnosed peripheral arterial disease
- Presence of untreated phlebitis, or septic phlebitis
- Diagnosed progressed arterial insufficiency including ischemia
- Diagnosed congestive heart failure
- Diagnosed clinically relevant hypertension
- Diagnosed renal insufficiency or kidney failure
- Presence of Untreated or progressing skin infection
- Presence of large coagulum in the leg vein
- Presence of phlegmasia coerulea dolens
- Diagnosed Raynaud's disease
- Diagnosed gonarthrosis
- Diagnosed ankle arthrosis
- Diagnosed rheumatoid arthritis
- Presence of Exuding dermatoses
- Presence of gangrene
- Diagnosed malign lymphedema
- Diagnosed psoriasis
- Diagnosed diabetes mellitus
- Diagnosed complex regional pain syndrome (CRPS; Sudeck atrophy)
- Diagnosed polyneuropathy
- Diagnosed severe impaired skin sensitivity und impaired sensitivity of the extremities, including all sensory malfunctions and diagnosed impaired pain sensitivity
- Objections of the investigator to the subject's participation in the trial due to medical reasons or any other reason for which the subject should not participate in the opinion of the investigator
- Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel
- Sponsors, manufacturers or CRO staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explorative, Monocentric, Feasibility Study Focusing on Fit of Innovative, Made-to-measure Compression Garments in Healthy Subjects
Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.
Read the detailed description
Lower and upper extremities of 36 health subjects will be measured be trained experts to collect measures for made-to-measure compression garments.
Fit of made-to-measure compression garments, which are not on the market yet, among healthy subjects will be tested on one day, simulating daily activities. Fit will be assessed directly after donning and after a wearing period of maximum 7 hours at the study site by trained experts. Healthy subjects will give back study products at the end of the wearing period. AEs will be documented throughout the study.
- Conditions
- Product Use Issue
- Being tested
- Made-to-measure compression garment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Made-to-measure compression garmentDevice
Made-to-measure compression garment
| Study group | Role | What they receive |
|---|---|---|
| Fit test of made-to-measure garments | Other | Healthy subjects will test maximum 2 compression garments out of 6 garments under investigation Receives: Device: Made-to-measure compression garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the fit of the investigational device
Evaluation of the fit of the investigational medical device at the end of a wearing period of approximately 4 - 7 hours by predefined criteria, to be worn by healthy subjects once.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start28 Nov 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Product Use IssueStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy subjects will test made-to-measure compression garments. No comparator group due to exploartive design
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Kröncke, Principal investigator, Bioskin GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181580
- Sponsor's protocol ID
- BSN-C2593
- Status last verified
- Jan 2020
- First submitted
- 26 Nov 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. Data are needed for confidential medical device development.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative, Monocentric, Feasibility Study Focusing on Fit of Innovative, Made-to-measure Compression Garments in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04181580
- Acronym / sponsor ID
- BSN-C2593
- Conditions
- Product Use Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 29 Nov 2019 (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.
Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.
Detailed description
Lower and upper extremities of 36 health subjects will be measured be trained experts to collect measures for made-to-measure compression garments.
Fit of made-to-measure compression garments, which are not on the market yet, among healthy subjects will be tested on one day, simulating daily activities. Fit will be assessed directly after donning and after a wearing period of maximum 7 hours at the study site by trained experts. Healthy subjects will give back study products at the end of the wearing period. AEs will be documented throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy subjects will test made-to-measure compression garments. No comparator group due to exploartive design
| Arm | Type | Receives |
|---|---|---|
| Fit test of made-to-measure garments | Other | Device: Made-to-measure compression garmentHealthy subjects will test maximum 2 compression garments out of 6 garments under investigation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men, women or diverse
- Full legal competence
- Age between 18 and 70 years
- Capability to understand the subject information and to provide conscious informed consent
- All female or diverse subjects of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a Pearl-Index of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner for at least 4 weeks
Key exclusion criteria (41 listed)
- Circumference of the largest circumference of the upper leg >80 cm (measured in the upright position)
- Shape distortions
- Diagnosed lymphedema of the upper and/or lower extremities
- Diagnosed lipedema of upper and/or lower extremities
- Diagnosed indication for therapy with flat-knitted compression garments
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 |
|---|---|---|
| Made-to-measure compression garmentMade-to-measure compression garment | Device | Fit test of made-to-measure garments |
Primary outcome
Evaluation of the fit of the investigational device
Time frame: One day
Evaluation of the fit of the investigational medical device at the end of a wearing period of approximately 4 - 7 hours by predefined criteria, to be worn by healthy subjects once.
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 18 Jan 2020.
- Individual participant dataSharing planned: No. No IPD will be shared. Data are needed for confidential medical device development.
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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.
Uwe Kröncke principal investigator
Bioskin GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Made-to-measure compression garment in people with Product Use Issue, run by BSN Medical GmbH at 1 site in Germany.
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 9 inclusion and 41 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 18 Jan 2020. 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 Germany. 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?
Evaluation of the fit of the investigational device (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.