A first in human study evaluating the safety and efficacy of TetraDERM device (a water-based solution) for scar management in subjects with a planned surgical procedure and surgical incision to the trunk, arm or legs

Tetratherix Technology Pty Ltd0 个研究点目标入组 45 人开始时间: 2024年8月8日最近更新: 2024年9月2日

适应症

试验速览

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•1. Subject or legally authorised representative must sign an Informed Consent Form(ICF) indicating that he/she/they understand the purpose of, and procedures required for the study and is willing to participate for the entire duration.
•2. In the Investigator’s opinion, the subject is able to understand and comply with the protocol requirements and is likely to complete the study as planned.
•3. Female subjects must have a negative serum (ß human chorionic gonadotropin) pregnancy test at screening and negative urine pregnancy test prior to procedure.
•4. Male subjects must use adequate contraception (as defined in the informed consent) from Screening and throughout the duration of the study and 12 month follow up period.
•5. Subject may have a BMI of 18.0 to 35.0 kg/m2, extremes included.
•Cohort 2 Only
•6. Subjects between the age of 18 and 75 years at the time of enrollment.
•7. Subjects who have treatment planned that includes a surgical incision equal to 3cm and equal or less than 15cm in areas on face and neck.
•Cohort 3 only
•6. Subjects between the age of 18 and 75 years at the time of enrollment.
•7. Participants that have treatment planned that includes bilateral breast reduction (mastopexy or Wise Pattern) and/or abdominoplasty and/or Circumferential lipectomy and/or bilateral thigh reduction and bilateral arm reduction surgeries.

•1. Subjects with surgical incisions with expected wound length that do not meet their cohort criteria.
•2. Subjects who require more than 1 surgical incision.
•3. Subjects with surgical incisions with expected wound length that in total exceeds 1.8 m (180 cm).
•4. Subjects with acute infection at the target site or a surgical site located near infection.
•5. Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study.
•6. Subjects with a positive drug screen including amphetamines, benzodiazepines, cocaine, opioids, methadone and barbiturates for the duration of the study.
•7. Subjects who smoke tobacco.
•8. Subjects who are concurrently enrolled in another clinical study, or who have or received an investigational device or drug within the past eight (8) weeks.
•9. Subjects with a history of a psychological illness or condition such as to interfere with the Subject's ability to understand the requirements of the study.
•10. Subjects with diagnosed fibromyalgia.
•11. Subjects unwilling or unlikely, in the Principal Investigator’s opinion, to comply with the study follow-up.
•12. Subjects who are undergoing or are planned to undergo an immunosuppressive therapy

发起方

Tetratherix Technology Pty Ltd