A Clinical Trial for the Interventional Robotic System

Not Applicable

Recruiting

• Conditions: Cerebral Angiography
• Interventions: Device: Interventional Robotic System

• Registration Number: NCT05778214
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-23
• Study Start: 2023-02-28
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-18
• Last Update Submitted: 2023-03-18
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2024-01-31
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Robotic System Assisted Surgery	Interventional Robotic System	Experimental group underwent cerebral angiography using the vascular interventional surgical control system

Primary Outcome Measures

Name	Time	Method
Clinical Success Rate	at the end of surgery	Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means.

Secondary Outcome Measures

Name	Time	Method
Super-selective Catheterization Time for Target Vessels	at the end of surgery	Calculate and compare the average time taken to perform super-selective catheterization for each target vessel during each surgical procedure.
Super-selective Technique Success Rate	at the end of surgery	Assessing the technical success rate of the surgical physician in performing super-selective catheterization of cerebral vessels through the operation of experimental instruments or artificial means.
Instrument Performance Evaluation	at the end of surgery	The surgical physician fills out a form after the surgery to subjectively evaluate the performance of the experimental instruments during the angiographic examination procedure.
DSA Fluoroscopy Time	at the end of surgery	Record and compare the duration of fluoroscopy during DSA for each surgical procedure.
Surgical Time	at the end of surgery	Record and compare the duration of each surgical procedure.
Primary Operator Radiation Absorbed Dose	at the end of surgery	Record and compare the absorbed dose of ionizing radiation received by the primary operator during each surgical procedure.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai City, China