A Clinical Trial for the Interventional Robotic System

NCT05778214 | Unknown DMC

• 1 other identifier: P01-QR-003
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Angiography

Keywords

Cerebral Angiography; Interventional Surgical Robot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Super-selective Technique Success Rate

  at the end of surgery

• Super-selective Catheterization Time for Target Vessels

  at the end of surgery

• DSA Fluoroscopy Time

  at the end of surgery

• Surgical Time

  at the end of surgery

• Primary Operator Radiation Absorbed Dose

  at the end of surgery

Study Arms (2)

Interventional Robotic System Assisted Surgery

EXPERIMENTAL

Experimental group underwent cerebral angiography using the vascular interventional surgical control system

Device: Interventional Robotic System

Traditional Manual Surgery

NO INTERVENTION

The control group process the traditional manual operation for cerebral angiography

Interventions

Interventional Robotic System DEVICE

Cerebral angiography was performed by using the interventional robotic system

Interventional Robotic System Assisted Surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 85 years;
• Plan to undergo cerebral angiography;
• Voluntarily participated in this trial and signed the informed consent form.

You may not qualify if:

• Preoperative mRS score \>2;
• Allergy or intolerance to iodine contrast media;
• Allergy to interventional devices;
• Severe cardiac, hepatic and renal insufficiency;
• Active systemic infection;
• Severe stenosis, occlusion or skin infection at the puncture site;
• Subjects who are to undergo surgery at the same time as cerebral angiography;
• Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin);
• Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening;
• Female subjects of childbearing age who are pregnant or breastfeeding;
• Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai City, China

RECRUITING

Related Publications (1)

• Zhang Y, Xu H, Sun J, Chen WH, Zhang Y, Chen M, Yi T, Wu YM, Cheng G, Guo J, Yang P, Guo S, Liu J. Safety and efficacy of cerebral robot assisted angiography: randomized comparison of robotic versus manual procedures. J Neurointerv Surg. 2025 Jul 9:jnis-2025-023412. doi: 10.1136/jnis-2025-023412. Online ahead of print.

  PMID: 40633938 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the Department of Neurosurgery

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 21, 2023
• Study Start: February 28, 2023
• Primary Completion: January 31, 2024
• Study Completion: December 1, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

CN (1)