A Clinical Study to Determine the Safety and Efficacy of Bio-Ray Knee Guard in Panelists with Varicose Vein and Knee Pain.

NovoBliss Research

Status: Completed

Conditions: Varicose Veins with Self-declared Knee Pain

Treatments: Device: Bio-Ray Knee Guard

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06440889

NB240023-WU

Details and patient eligibility

About

Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with varicose vein and Self-Declared Knee Pain.

Sample size for this proof-of-science study is kept 32 panelists aged 35 to 70 years with self-declared knee pain and varicose veins will be enrolled and 32 healthy panelists will be enrolled.

Full description

Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent.

Panelists shall be instructed to visit the facility for the following scheduled visits:

Visit 01 (Day 01): Screening, enrolment, evaluations at baseline, test product and *subject diary distribution, followed by evaluations after 1 hour (+10 minutes).

Visit 02 (Day 03 +1 day): Evaluations at Day 03 (+1 day).

Visit 03 (07 ±2 days): 1-week evaluations at Day 07 (±2 days).

Visit 04 (28±2 days): Subject diary review, followed by end of study evaluations.

Enrollment: 63 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Panelists of either gender, aged from 35 to 70 years (both inclusive) at the time of informed consent.
2. Non-pregnant and non-lactating adult females having a self-reported negative urine pregnancy test.
3. Panelist of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, vasectomy or abstinence).
4. 32 panelists with clinical diagnosis of varicose veins in any of the leg with C2 class as per CEAP classification (Appendix II), with self-declared knee pain.
5. 32 healthy panelists will be enrolled.
6. Documented written informed consent from the panelists.
7. Panelists having willingness and ability to adhere to study directions, and agreeing not to use any other or wear any other similar product at the same designated site for this study and returning for all specified visits for follow-up.
8. Panelists are currently not enrolled in an active investigational study or have participated in similar investigational study within 30 days prior to enrolment.

Exclusion criteria

1. Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the panelists unfit to take part in the study.
2. Any recent surgery which may hinder in the study specific assessments and overall outcome.
3. Panelists with class C3 to C6 of CEAP classification.
4. Panelists who are currently on medication therapy for varicose veins, deep vein thrombosis or chronic venous insufficiency.
5. Panelists taking or have taken medication(s) which, in the Investigator's judgment, make them ineligible or places them at undue risk.
6. Panelists are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
7. Females who are pregnant or breastfeeding or planning to become pregnant during the study period.
8. Panelists who are not willing to adhere to the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Varicose Vein Group

Experimental group

Description:

Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours.

Treatment:

Device: Bio-Ray Knee Guard

Healthy Group

Other group

Description:

Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours.

Treatment:

Device: Bio-Ray Knee Guard