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Design of a Medical Device for Oxaliplatin-Induced Peripheral Neuropathy Considering the Patient's Voice in Gastrointestinal Cancer
This is an observational study related to a medical device designed for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with gastrointestinal cancer. The primary objective is to collect data through interviews with patients experiencing OIPN symptoms to co-design the medical device prototype, incorporating the patient's perspective. Additionally, the study aims to identify clinical and usability patterns that will help optimize the design of a future clinical investigation assessing the safety and efficacy of the final device.
Main Hypothesis: The clinical data collected from patient interviews, along with their active participation in the co-design of the localized cooling medical device, likely in the form of gloves, will enable the design of both the functional prototype and the future clinical research on safety and efficacy. This approach will increase the likelihood of patient acceptance of the medical device treatment and help identify different patient profiles that could benefit the most from it. Secondary Hypotheses: 1. Patients will be able to easily adhere to the use of the device during chemotherapy. 2. The final glove design, in terms of materials and structure, will be suitable for commercial manufacturing and will have a viable demand among patients and healthcare providers. 3. There is no difference in treatment adherence between men and women or among people of different ages.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Start Date
April 1, 2025
Primary Completion Date
November 30, 2025
Completion Date
December 30, 2025
Last Updated
March 10, 2026
50
ACTUAL participants
Clinical interviews with patients and Usability interviews and glove testing.
OTHER
Lead Sponsor
Corporacion Parc Tauli
NCT07423390
NCT06736600
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07203066