Peripheral Arterial DiseaseNCT05625711
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
A study of Peripheral Arterial Disease, run by Shanghai Operation Robot Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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
- Conditions
- Peripheral Arterial Disease
- Being tested
- The endovascular interventional surgical instrument control system
- Keywords
- robot, peripheral arterial
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The endovascular interventional surgical instrument control systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted surgery | Experimental | 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 Receives: Device: The endovascular interventional surgical instrument control system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after operation
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.
Measured: immediately after operation
Secondary outcomes (3)
Rutherford grading change
The surgeon evaluated the subjects' symptoms of lower limb ischemia according to the Rutherford scale [13].
Measured: 4 days after surgery or discharge (depending on which comes first)
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.
Measured: The whole process from the beginning to the end of the operation was recorded.
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.
Measured: Immediately after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Operation Robot Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital, Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625711
- Sponsor's protocol ID
- XMLY3001-02A
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05625711
- Acronym / sponsor ID
- XMLY3001-02A
- Conditions
- Peripheral Arterial Disease
- Keywords
- robot, peripheral arterial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Shanghai Operation Robot Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Changhai Hospital, Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot assisted surgery | Experimental | Device: The endovascular interventional surgical instrument control systemThe 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet all the following criteria to be included in the group.
Key exclusion criteria (9 listed)
- General criteria: If any of the following criteria is met, it cannot be included in the group.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The endovascular interventional surgical instrument control systemThe 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. | Device | Robot assisted surgery |
Primary outcome
Equipment technical success rate
Time frame: immediately after operation
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
Time frame: immediately after operation
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.
3 secondary outcomes
Rutherford grading change
Time frame: 4 days after surgery or discharge (depending on which comes first)
Total radiation exposure per operation (surgeon, subject operating table side)
Time frame: The whole process from the beginning to the end of the operation was recorded.
Satisfaction rate of equipment operation (convenience, stability)
Time frame: Immediately after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study of Peripheral Arterial Disease, run by Shanghai Operation Robot Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lu qingsheng, MD (021-31166666, luqs@newvascular.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equipment technical success rate (time frame: immediately after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.