Clinical trial: Bodytrak® Feasibility Study (NCT03139955)

Eligibility criteria:
Inclusion Criteria

        In order to be able to participate in this study, an individual must meet all of the
        following criteria:

          1. Participant is willing and able to give informed consent for participation in the
             study.

          2. Stated willingness to comply with all study procedures and availability for the
             duration of the study.

          3. Male or female.

          4. Age of ≥ 18 years at screening.

          5. BMI between ≥19.0 and ≤30.0, inclusive.

          6. An in-patient hospital stay in the high dependency unit of at least 2 days following
             elective general surgery at Chelsea and Westminster Hospital.

          7. American Society of Anaesthesiologist (ASA) Physical status classification System 1-2

          8. Willing to allow his or her General Practitioner and consultant, if appropriate, to be
             notified of participation in the study.

        Exclusion Criteria

        The participant may not enter the study if ANY of the following apply:

          1. Presence of a cardiac pacemaker.

          2. Current or history of clinically significant cardiovascular disease, condition or
             abnormality including coronary artery disease, myocardial infarction, abnormal heart
             rhythms or arrhythmias, heart failure, heart valve disease, congenital heart disease,
             cardiomyopathy as determined by the physical exam or medical history review.

          3. Use of the following cardiac drugs: beta blockers, calcium channel blockers,
             angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers/inhibitors
             or digitalis preparations within 3 months of Screening.

          4. Current infection or condition of the right ear as determined by the Right Ear Exam or
             documented in medical history questionnaire, which may be exacerbated by the use of
             Bodytrak in the opinion of the investigator.

          5. Patients who are on the ventilator and are persistently unconscious throughout their
             stay in the HDU.

          6. Hypersensitivity or allergy to any of the Bodytrak materials that are in contact with
             the skin - SLA, PLA (3D printer resins), black Pro Flex 50 (Rubber), clear vacuum cast
             40/55 shore silicone, and black anodised aluminium.

          7. Patient known to have resistant organisms including Vancomycin-Resistant Enterococcus
             (VRE), Extended-Spectrum Beta-Lactamase (ESBL) & Methicillin-Resistant Staphylococcus
             aureus (MRSA), meaning Bodytrak would be unable to be cleaned using the approved
             cleaning protocol.

          8. Any hearing impediment that, in the opinion of the investigator, would not be
             compatible with the use of Bodytrak.

          9. Bodytrak not compatible to fit securely and correctly in the patient's right ear.

         10. Participant unwilling to wear Bodytrak for the durations stated in the study protocol
             due to comfort and/or preference issues.

         11. Pain reported during Right Ear Pain Assessment at screening

         12. Currently participating in another clinical trial with an investigational or
             non-investigational drug or device, or has participated in another clinical trial
             within 3 months preceding Day 1.

         13. Any condition that, in the opinion of the investigator, compromises the participant's
             ability to meet protocol requirements or to complete the study.

         14. Unable to read and speak English to a fluency level adequate for the full
             comprehension of procedures required in participation and consent.

         15. Patient refusal
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? 0