A Clinical Trial for the Interventional Robotic System

A Multi-Center, Randomized, Non-Inferiority, Prospective and Parallel-Group Trial to Evaluate the Safety and Efficacy of the Interventional Robotic System for Cerebral Angiography

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 Overview

• Status: Recruiting
• Conditions: Cerebral Angiography
• Intervention / Treatment: Device: Interventional Robotic System

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai City
    • Shanghai, Shanghai City, China
      • Recruiting
      • Changhai Hospital
      • Contact: Jianming liu; Phone Number: 008613901780638; Email: chzhanghj@smmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Robotic System Assisted Surgery; Experimental group underwent cerebral angiography using the vascular interventional surgical control system	Device: Interventional Robotic System; Cerebral angiography was performed by using the interventional robotic system
No Intervention: Traditional Manual Surgery; The control group process the traditional manual operation for cerebral angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Super-selective Technique Success Rate	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.	at the end of surgery
Super-selective Catheterization Time for Target Vessels	Calculate and compare the average time taken to perform super-selective catheterization for each target vessel during each surgical procedure.	at the end of surgery
DSA Fluoroscopy Time	Record and compare the duration of fluoroscopy during DSA for each surgical procedure.	at the end of surgery
Surgical Time	Record and compare the duration of each surgical procedure.	at the end of surgery
Primary Operator Radiation Absorbed Dose	Record and compare the absorbed dose of ionizing radiation received by the primary operator during each surgical procedure.	at the end of surgery
Instrument Performance Evaluation	The surgical physician fills out a form after the surgery to subjectively evaluate the performance of the experimental instruments during the angiographic examination procedure.	at the end of surgery

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cerebral Angiography; Interventional Surgical Robot
• Other Study ID Numbers: P01-QR-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No