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A Clinical Trial for the Interventional Robotic System

N

Naval Military Medical University

Status

Enrolling

Conditions

Cerebral Angiography

Treatments

Device: Interventional Robotic System

Study type

Interventional

Funder types

Other

Identifiers

NCT05778214
P01-QR-003

Details and patient eligibility

About

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.

Enrollment

142 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

142 participants in 2 patient groups

Interventional Robotic System Assisted Surgery
Experimental group
Description:
Experimental group underwent cerebral angiography using the vascular interventional surgical control system
Treatment:
Device: Interventional Robotic System
Traditional Manual Surgery
No Intervention group
Description:
The control group process the traditional manual operation for cerebral angiography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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