Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy Due to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical interviews with patients and Usability interviews and glove testing. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational group of patients with gastrointestinal cancer treated with oxaliplatin.
- interventionNames
- Other: Clinical interviews with patients and Usability interviews and glove testing.
Primary outcomes (1)
- measure
- Co-design a medical device with patients to develop a solution that can prevent the onset of oxaliplatin-induced peripheral neuropathy (OIPN)
- timeFrame
- From baseline to 6 months
- description
- Interviews will be conducted with patients to gather information on the clinical presentation of oxaliplatin-induced peripheral neuropathy and its impact on patients' quality of life.
Secondary outcomes (3)
- measure
- Gain an in-depth understanding of the progression of OIPN symptoms.
- timeFrame
- From baseline to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Outpatient patient with gastrointestinal cancer treated with oxaliplatin. * Having completed at least three cycles of chemotherapy. * Presenting acute or chronic symptoms of chemotherapy-induced peripheral neuropathy. * The study will include individuals over 18 years old. Gender identify will be collected confidentially and inclusively, offering options for non-binary individuals and those who prefer not to identify with binary categories. Exclusion Criteria: * Patient with osteoarthritis or arthritis in the hands. * Diagnosis of any autoimmune disease affecting connective tissue, such as: rheumatoid arthritis, Raynaud's syndrome, lupus, scleroderma, dermatomyositis, vasculitis, or cryoglobulinemia.
References
Publications (0)
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