A Study to Evaluate the Use of a Novel Wearable Device for Temperature Monitoring in Cancer Patients Who Underwent Autologous Stem Cell Transplant
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 17-003922
Sponsor Protocol Number: 17-003922
About this study
The purpose of this study is to evaluate the performance of the wearable tPatch device when compared to an oral temperature measuring device in patients who have undergone a post-autologous bone marrow transplant.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Subjects at least 18 years of age
- Subjects able to read, understand, and complete the informed consent form
- Subjects treated for cancer and scheduled to undergo autologous stem cell transplant at Mayo Clinic, Rochester, MN
- Subjects able to wear wearable temperature sensing device(s) for the duration of the study
- Subjects able to record body temperature per the protocol for the duration of the study
- Subjects pregnant or breastfeeding
- Subjects with leukemia
- Subjects diagnosed with renal failure based on estimated glomerular filtration rate (eGFR) for age, size, gender and race norms
- Subjects with ECOG performance status of 2 and greater
- Subjects with known allergies to medical grade adhesives
- Subjects with known cutaneous hypersensitivity
- Subjects with impaired decision-making capabilities
- Subjects with wireless medical devices or implantable electronic medical devices (e.g., pacemakers, implantable defibrillators, and spinal stimulators)
- Subjects febrile at time of enrollment or placement of the tPatch device
- Any additional condition or situation that, in the opinion of the Investigator, makes the subject inappropriate for participation in the study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available