Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma

Sponsor
Batea Oncology
Study ID
NCT07725640
Status
Not Yet Recruiting

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Conditions

  • Glioma
  • High-Grade Glioma (HGG)
  • Surgical Resection

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • GlioHook device — DEVICE
    GlioHook is a sterile medical device designed to be implanted after tumour resection surgery in suspected high grade glioma patients, covering the entire surface of the tumour resection margins.

Study Details

This is a prospective, multicenter, single-arm, pilot clinical investigation, aimed at evaluating the safety and preliminary efficacy of the GlioHook implant in patients with high-grade glioma undergoing surgical resection followed by standard of care (SoC) treatment. GlioHook is a sterile medical device designed to be implanted after tumour resection surgery in suspected high grade glioma patients, covering the entire surface of the tumour resection margins, decreasing infiltration and focalizing the disease, while improving the effects of radiotherapy. Once implanted, GlioHook exerts a dual mechanism that combines tumour cell focalization and radiosensitization.

Key Dates

First listed
Jul 24, 2026
Start date
Oct 30, 2026
Status verified
Jul 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Experimental Arm
    GlioHook implant in patients with high-grade glioma undergoing surgical resection followed by standard of care (SoC) treatment.

Primary Outcome Measure

To evaluate the safety of the GlioHook implant, as measured by the occurrence of adverse events related to the GlioHook implant, as well as events involving the need for device removal [ Time Frame: 24 months ]

Central Contacts

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