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To evaluate the feasibility, efficacy and safety of percutaneous interventional control system for radioactive particle implantation in a prospective, single-center, single-group clinical trial

To evaluate the feasibility, efficacy and safety of percutaneous interventional control system for radioactive particle implantation in a prospective, single-center, single-group clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092683
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-10-12
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic, abdominal, or pelvic tumors

Interventions

experimental group:Radioactive particle implantation

Sponsors

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age >=18 years old, no gender limitation; 2) Patients who relapsed after surgery or external radiotherapy, or refused surgery or external radiotherapy; 3) Patients with thoracic, abdominal, or pelvic tumors who have indications for radioactive particle implantation as assessed by the investigator; 4) Those who signed the informed consent form and volunteered to participate in this clinical trial; 5) Be able to understand the trial and cooperate with the trial procedures, and be able to follow up as required.

Exclusion criteria

Exclusion criteria: 1) Contraindications of radioactive particle implantation surgery a) Patients with severe bleeding tendency, platelet count 18s, prothrombin activity < 40%); b) Rupture of the tumor; c) Severe diabetes; d) No appropriate puncture path as assessed by the investigator; e) The expected planned target dose does not meet the requirements of the prescription dose design; 2) Patients with severe liver and kidney function impairment who could not tolerate surgery as assessed by the investigators; 3) Women who were pregnant, lactating, or planned to have children during the trial; 4) Patients with addiction to drugs, alcohol, etc; 5) Suffering from mental illness, no self-control, unable to express clearly; 6) Participants who had participated in clinical trials of other drugs, biologics, or medical devices before screening and did not meet the time limit for the primary end point; 7) Other conditions that the investigator considers inappropriate for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Success rate of puncture;Incidence of surgical complications;Incidence of device defects;Incidence of adverse events and serious adverse events;

Secondary

MeasureTime frame
Number of puncture adjustments;Duration of surgery;Device performance evaluation;

Countries

China

Contacts

Public ContactZhiyuan Wu

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

wzy11549@rjh.com.cn+86 135 6462 0606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026