NCT07137195

Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei)

Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS for Radiation Therapy in Oncology Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Ion Beam Applications · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device. The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.

Detailed description

The trial is structured in two distinct phases. Phase 1 - Clinical Trial: This phase spans from the initial screening through to 90 days post-treatment. Its primary objective is to assess the efficacy and safety of PROTEUS® PLUS in accordance with the regulatory requirements set by the National Medical Products Administration (NMPA) for product registration. Phase 2 - Long-Term Follow-Up: Extending up to five years after treatment, this phase aims to monitor the long-term efficacy and safety of PROTEUS® PLUS. Periodic reports will be submitted in compliance with NMPA guidelines.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DEVICE	Proton Beam Therapy (PBT)	PROTEUS® PLUS

Timeline

• Start date: 2025-04-29
• Primary completion: 2026-09-05
• Completion: 2031-07-31
• First posted: 2025-08-22
• Last updated: 2026-02-27

Locations

1 site across 1 country: China