Back to resultsClinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
Primary Purpose
Peripheral Arterial Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The endovascular interventional surgical instrument control system
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring robot, peripheral arterial
Eligibility Criteria
Inclusion Criteria: Meet all the following criteria to be included in the group. Age: 18 years old or above, regardless of gender. Suffering from arteriosclerosis obliterans of lower limbs, it has the indication of endovascular treatment. Volunteer to participate in the test and sign the informed consent form. Exclusion Criteria: General criteria: If any of the following criteria is met, it cannot be included in the group. Pregnant or lactating women, or women of childbearing age with positive pregnancy test results. The target vessels were treated by arterial bypass grafting. Subjects participated in other clinical trials within 3 months before the screening period. Allergic history or contraindication of antiplatelet drugs, anticoagulants, anesthetics, contrast agents, scaffold materials and their coating drugs. Severe infection that is difficult to control. Vascular criteria: According to the CTA judgment of the diseased vessels, if any of the following criteria is met, they can not be included in the group. Perforation, dissection or aneurysm of the diseased vessel or the proximal vessel of the diseased vessel. The investigator believed that the vascular conditions were not suitable for the use of the test medical device.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot assisted surgery
Arm Description
The robot will assist doctors to complete lower limb artery surgery, including but not limited to the transfer and withdrawal of guide wire, catheter and stent
Outcomes
Primary Outcome Measures
Equipment technical success rate
After the endovascular treatment was completed by the surgeon using the experimental medical instrument, the proportion of subjects with successful equipment technology was achieved in the total enrolled subjects.
Surgical technique success rate
The proportion of subjects with successful surgical technique in the total enrolled subjects was achieved after the intravascular treatment of lower extremity arteriosclerosis occlusion with experimental medical instruments.
Secondary Outcome Measures
Rutherford grading change
The surgeon evaluated the subjects' symptoms of lower limb ischemia according to the Rutherford scale [13].
Total radiation exposure per operation (surgeon, subject operating table side)
Determination method:
The surgeon wears a radiation measuring device on his chest to record the total radiation exposure during surgery.
Radiation measuring devices were placed around the umbilicus to record the total radiation exposure during surgery.
Simulate the maximum total unguarded radiation exposure of the primary operator with full manual operation.
Satisfaction rate of equipment operation (convenience, stability)
Scores of the Equipment Operation Evaluation Scale (Convenience, stability) used by surgeons who used experimental medical instruments to complete endovascular treatment of lower extremity arteriosclerosis occlusion.
Full Information
NCT ID
NCT05625711
First Posted
October 26, 2022
Last Updated
November 22, 2022
Sponsor
Shanghai Operation Robot Co., Ltd.
Collaborators
Changhai Hospital, Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05625711
Brief Title
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
Official Title
A Prospective, Multicenter, Single-arm Clinical Study Was Conducted to Evaluate the Safety and Efficacy of Intravascular Interventional Surgical Instrument Control System and Related Consumables for Remote Delivery, Operation, and Withdrawal of Interventional Surgical Instruments (Guide Wire, Catheter, Stent, Balloon) During Endovascular Interventional Surgery for Lower Extremity Arteriosclerosis Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Operation Robot Co., Ltd.
Collaborators
Changhai Hospital, Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial was a prospective, multicenter, single-group design. To undergo endovascular treatment of lower extremity arteriosclerosis obliterans After the subjects were selected and enrolled, the surgeons used the endovascular interventional surgical instrument control system developed by Shanghai Aopeng Medical Technology Co., Ltd. and the consumables of the endovascular interventional surgical instrument control system for the interventional hand Instrumentation (guide wire, catheter, stent, balloon) for remote delivery, manipulation, and withdrawal
Detailed Description
This study will verify the safety and effectiveness of the device in human peripheral vascular diseases, and verify 1. the degree of precision of its operation 2. the function of reducing radiation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
robot, peripheral arterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot assisted surgery
Arm Type
Experimental
Arm Description
The robot will assist doctors to complete lower limb artery surgery, including but not limited to the transfer and withdrawal of guide wire, catheter and stent
Intervention Type
Device
Intervention Name(s)
The endovascular interventional surgical instrument control system
Intervention Description
The endovascular interventional surgical instrument control system is based on the analysis of the operation behavior of doctors and their assistants in the process of manual intervention. It simulates the coordinated movement of four manipulators, completes the advance and retreat of the catheter and guide wire cavity, and realizes the different actions of wire feeding along the tube, wire feeding along the wire, wire twisting coordination, wire replacement, stent release, etc.
Primary Outcome Measure Information:
Title
Equipment technical success rate
Description
After the endovascular treatment was completed by the surgeon using the experimental medical instrument, the proportion of subjects with successful equipment technology was achieved in the total enrolled subjects.
Time Frame
immediately after operation
Title
Surgical technique success rate
Description
The proportion of subjects with successful surgical technique in the total enrolled subjects was achieved after the intravascular treatment of lower extremity arteriosclerosis occlusion with experimental medical instruments.
Time Frame
immediately after operation
Secondary Outcome Measure Information:
Title
Rutherford grading change
Description
The surgeon evaluated the subjects' symptoms of lower limb ischemia according to the Rutherford scale [13].
Time Frame
4 days after surgery or discharge (depending on which comes first)
Title
Total radiation exposure per operation (surgeon, subject operating table side)
Description
Determination method:
The surgeon wears a radiation measuring device on his chest to record the total radiation exposure during surgery.
Radiation measuring devices were placed around the umbilicus to record the total radiation exposure during surgery.
Simulate the maximum total unguarded radiation exposure of the primary operator with full manual operation.
Time Frame
The whole process from the beginning to the end of the operation was recorded.
Title
Satisfaction rate of equipment operation (convenience, stability)
Description
Scores of the Equipment Operation Evaluation Scale (Convenience, stability) used by surgeons who used experimental medical instruments to complete endovascular treatment of lower extremity arteriosclerosis occlusion.
Time Frame
Immediately after
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events (equipment-related, all-cause)
Description
The proportion of subjects with an adverse event (equipment-related, all-cause) among all subjects.
Time Frame
Intraoperative to postoperative 4 days or discharge day (depending on which comes first)
Title
Incidence of device defects (software, hardware)
Description
The proportion of subjects with device defects (software, hardware) in total subjects.
Time Frame
intraoperative.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet all the following criteria to be included in the group.
Age: 18 years old or above, regardless of gender.
Suffering from arteriosclerosis obliterans of lower limbs, it has the indication of endovascular treatment.
Volunteer to participate in the test and sign the informed consent form.
Exclusion Criteria:
General criteria: If any of the following criteria is met, it cannot be included in the group.
Pregnant or lactating women, or women of childbearing age with positive pregnancy test results.
The target vessels were treated by arterial bypass grafting.
Subjects participated in other clinical trials within 3 months before the screening period.
Allergic history or contraindication of antiplatelet drugs, anticoagulants, anesthetics, contrast agents, scaffold materials and their coating drugs.
Severe infection that is difficult to control.
Vascular criteria: According to the CTA judgment of the diseased vessels, if any of the following criteria is met, they can not be included in the group.
Perforation, dissection or aneurysm of the diseased vessel or the proximal vessel of the diseased vessel.
The investigator believed that the vascular conditions were not suitable for the use of the test medical device.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lu qingsheng, MD
Phone
021-31166666
Email
luqs@newvascular.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
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