NCT06873360

Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients

Design of a Medical Device for Oxaliplatin-Induced Peripheral Neuropathy Considering the Patient's Voice in Gastrointestinal Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Neuropathy Due to Chemotherapy

Interventions

Type	Name	Description
OTHER	Clinical interviews with patients and Usability interviews and glove testing.	Clinical interviews with patients: These will be conducted by nursing staff with an approximate total of 50 patients during their treatment at the Hospital. Each interview will last 15 minutes. Under no circumstances will the patient be required to answer any question. Usability interviews and glove testing: 10 patients selected from the previous interviews will test different gloves with various textures and levels of stiffness. Additionally, other questions will be asked focusing on refining the design. This evaluation will help determine the most suitable materials for the device's manufacturing, achieving a balance between comfort, discretion and functionality.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2025-03-12
• Last updated: 2026-03-10

Locations

1 site across 1 country: Spain