Feasibility Study Focusing on Fit of Made-to-measure Compression Garments in Healthy Subjects

NCT04181580 | Completed

• 1 other identifier: BSN-C2593
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.

Conditions

Product Use Issue

Outcome Measures

Primary Outcomes (1)

• 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.

  One day

Study Arms (1)

Fit test of made-to-measure garments

OTHER

Healthy subjects will test maximum 2 compression garments out of 6 garments under investigation

Device: Made-to-measure compression garment

Interventions

Made-to-measure compression garment DEVICE

Made-to-measure compression garment

Fit test of made-to-measure garments

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (1)

bioskin GmbH

Hamburg, 20095, Germany

Location

Study Officials

• Uwe Kröncke

  Bioskin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy subjects will test made-to-measure compression garments. No comparator group due to exploartive design

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: November 28, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)