A Clinical Trial for the Interventional Robotic System

Changhai Hospital142 enrolled

Overview

The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

142

Conditions

Cerebral Angiography

Interventions

Interventional Robotic SystemDEVICE

Cerebral angiography was performed by using the interventional robotic system

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 and ≤ 85 years; 2. Plan to undergo cerebral angiography; 3. Voluntarily participated in this trial and signed the informed consent form. Exclusion Criteria: 1. Preoperative mRS score \>2; 2. Allergy or intolerance to iodine contrast media; 3. Allergy to interventional devices; 4. Severe cardiac, hepatic and renal insufficiency; 5. Active systemic infection; 6. Severe stenosis, occlusion or skin infection at the puncture site; 7. Subjects who are to undergo surgery at the same time as cerebral angiography; 8. Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin); 9. Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening; 10. Female subjects of childbearing age who are pregnant or breastfeeding; 11. Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.

Locations (1)

Changhai Hospital

Shanghai, Shanghai City, China

RECRUITING

Outcomes

Primary Outcomes

Clinical Success Rate

Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means.