Liver DiseasesNCT06195917
Robotic-assisted Percutaneous Transhepatic Puncture
A study testing Robotic-assisted Interventional Percutaneous transhepatic puncture in people with Liver Diseases, run by Zhongda Hospital at 1 site in China.
Trial summary
This is a first-in-man study to investigate the feasibility and safety profile of the newly developed robotic system for percutaneous transhepatic interventional procedures, including biopsy and ablation. Participants who were clinically assessed in need of a liver lesion puncture were included in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Robotic-assisted Interventional Percutaneous transhepatic puncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2023to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older, with no gender restrictions. (2) clinically assessed and deemed in need of a liver lesion puncture. (3) with a intrahepatic lesion no less than 1 cm in diameter. (4)with liver function of Child-Pugh Class A or B. (5) agree to participate in this clinical trial and sign an informed consent form.
Who cannot join
- with severe liver cirrhosis or in a decompensated liver function state within the 3 months prior to screening and who have undergone abdominal paracentesis for the treatment of a large amount of ascites.
- with severe coagulation disorders during the screening period, characterized by a platelet count < 50×10^9/L, a prolonged PT time > 6s, and an international normalized ratio (INR) > 1.5.
- classified as NYHA heart function Grade III and IV during the screening period.
- with severe chronic obstructive pulmonary disease (COPD) or severe asthma during the screening period.
- with renal insufficiency during the screening period, defined by creatinine (Cr) or blood urea nitrogen (BUN/UREA) levels exceeding two times the upper limit of normal.
- unable to cooperate with surgical positioning and other requirements for surgery.
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- Pregnant or lactating women of childbearing age and other vulnerable groups.
- have participated in other interventional clinical trials within the month prior to the commencement of this trial.
- Other individuals who are deemed unsuitable for participation in this trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Jian Lu, MD
About this study
Official title: Evaluation of the Safety, Effectiveness and Usability of Robotic-assisted Interventional Percutaneous Transhepatic Puncture: A First-in-human Pilot Study
This is a first-in-man study to investigate the feasibility and safety profile of the newly developed robotic system for percutaneous transhepatic interventional procedures, including biopsy and ablation. Participants who were clinically assessed in need of a liver lesion puncture were included in this study.
Read the detailed description
In current clinical practice, surgeons mainly use personal experience as a judgment criterion to determine the insertion Angle and trajectory of the needle path. In the process of puncture surgery, surgeons will complete the positioning puncture in three-dimensional space based on the guidance of two-dimensional images and personal judgment. Among them, the lack of three-dimensional sense of space in two-dimensional images may cause inaccurate positioning of the puncture needle in three-dimensional space, and even lead to the deviation of the needle tip approach, resulting in inaccurate biopsy sampling or inaccurate anastomosis in the simulation of thermal field before ablation. In addition, during surgery, changes in the patient's own gravity, breathing movements, posture, or the application of force during needle insertion may cause soft tissue displacement, thereby reducing the accuracy of positioning. In general, in order to ensure the accuracy of puncture, doctors will insert needles repeatedly and perform multiple CT scans on patients, which will lead to low surgical efficiency, increased risk of puncture complications, and increased trauma and pain of patients. In addition, in the puncture operation for liver tumors, if the needle insertion path is not accurate and the needle path is adjusted repeatedly, the risk of the puncture needle carrying out tumor cells will increase, which may cause the metastasis and spread of cancer cells, which is also a big challenge for young doctors. The investigators aim to evaluate the safety, effectiveness and usability of robotic-assisted percutaneous transhepatic puncture in this prospective study.
- Conditions
- Liver Diseases
- Being tested
- Robotic-assisted Interventional Percutaneous transhepatic puncture
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted Interventional Percutaneous transhepatic punctureDevice
Robotic-assisted Interventional Percutaneous transhepatic puncture
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Robotic-assisted Interventional Percutaneous transhepatic puncture Receives: Device: Robotic-assisted Interventional Percutaneous transhepatic puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-time puncture success rate
One-time puncture success rate is defined as the rate of one-time of successful percutanoues transhepatic puncture
Measured: one day
Secondary outcomes (5)
Number of puncture attempts
Number of puncture attempts was defined as the total number of punctures until the puncture success
Measured: one day
Puncture accuracy
Puncture accuracy was defined as the Euclidean distance to the pre-defined target
Measured: one day
Planning time
Time from completion of the first CT scan to successful surgical planning of the target lesion
Measured: one day
Instrument performance evaluation
The performance of the system was evaluated by investigators, including system display stability evaluation,evaluation of maneuverability and stability of surgical planning cart, evaluation of operation and stability of central control platform,evaluation of maneuverability and stability of optical tracking vehicle,evaluation of maneuverability and stability of robotic manipulator.
Measured: one day
Incidence of adverse events
Safety of the device will be evaluated by reporting the incidence, severity and frequency of all Adverse Events (AE), related and unrelated to the device treatment.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start19 Sep 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Jian Lu, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195917
- Sponsor's protocol ID
- IRob-Zhongda001
- Status last verified
- Apr 2024
- First submitted
- 7 Dec 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Effectiveness and Usability of Robotic-assisted Interventional Percutaneous Transhepatic Puncture: A First-in-human Pilot Study
- ClinicalTrials.gov ID
- NCT06195917
- Acronym / sponsor ID
- IRob-Zhongda001
- Conditions
- Liver Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 8 Jan 2024 (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 is a first-in-man study to investigate the feasibility and safety profile of the newly developed robotic system for percutaneous transhepatic interventional procedures, including biopsy and ablation. Participants who were clinically assessed in need of a liver lesion puncture were included in this study.
Detailed description
In current clinical practice, surgeons mainly use personal experience as a judgment criterion to determine the insertion Angle and trajectory of the needle path. In the process of puncture surgery, surgeons will complete the positioning puncture in three-dimensional space based on the guidance of two-dimensional images and personal judgment. Among them, the lack of three-dimensional sense of space in two-dimensional images may cause inaccurate positioning of the puncture needle in three-dimensional space, and even lead to the deviation of the needle tip approach, resulting in inaccurate biopsy sampling or inaccurate anastomosis in the simulation of thermal field before ablation. In addition, during surgery, changes in the patient's own gravity, breathing movements, posture, or the application of force during needle insertion may cause soft tissue displacement, thereby reducing the accuracy of positioning. In general, in order to ensure the accuracy of puncture, doctors will insert needles repeatedly and perform multiple CT scans on patients, which will lead to low surgical efficiency, increased risk of puncture complications, and increased trauma and pain of patients. In addition, in the puncture operation for liver tumors, if the needle insertion path is not accurate and the needle path is adjusted repeatedly, the risk of the puncture needle carrying out tumor cells will increase, which may cause the metastasis and spread of cancer cells, which is also a big challenge for young doctors. The investigators aim to evaluate the safety, effectiveness and usability of robotic-assisted percutaneous transhepatic puncture in this prospective study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Robotic-assisted Interventional Percutaneous transhepatic punctureRobotic-assisted Interventional Percutaneous transhepatic puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older, with no gender restrictions. (2) clinically assessed and deemed in need of a liver lesion puncture. (3) with a intrahepatic lesion no less than 1 cm in diameter. (4)with liver function of Child-Pugh Class A or B. (5) agree to participate in this clinical trial and sign an informed consent form.
Key exclusion criteria (9 listed)
- with severe liver cirrhosis or in a decompensated liver function state within the 3 months prior to screening and who have undergone abdominal paracentesis for the treatment of a large amount of ascites.
- with severe coagulation disorders during the screening period, characterized by a platelet count < 50×10^9/L, a prolonged PT time > 6s, and an international normalized ratio (INR) > 1.5.
- classified as NYHA heart function Grade III and IV during the screening period.
- with severe chronic obstructive pulmonary disease (COPD) or severe asthma during the screening period.
- with renal insufficiency during the screening period, defined by creatinine (Cr) or blood urea nitrogen (BUN/UREA) levels exceeding two times the upper limit of normal.
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 |
|---|---|---|
| Robotic-assisted Interventional Percutaneous transhepatic punctureRobotic-assisted Interventional Percutaneous transhepatic puncture | Device | Experimental group |
Primary outcome
One-time puncture success rate
Time frame: one day
One-time puncture success rate is defined as the rate of one-time of successful percutanoues transhepatic puncture
5 secondary outcomes
Number of puncture attempts
Time frame: one day
Puncture accuracy
Time frame: one day
Planning time
Time frame: one day
Instrument performance evaluation
Time frame: one day
Incidence of adverse events
Time frame: three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
Jian Lu, MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted Interventional Percutaneous transhepatic puncture in people with Liver Diseases, run by Zhongda Hospital at 1 site in China.
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 1 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jian Lu, MD (+8615850654644, lujian43307131@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-time puncture success rate (time frame: one day). 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 19 Apr 2024.