Robotic Surgical ProcedureNCT05535712
Single Port Robotic Lung Anatomical Resection
A study testing Lung Anatomic Resection (Da Vinci SP) in people with Robotic Surgical Procedure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Robotic Surgical Procedure
- What is being tested?
- Lung Anatomic Resection (Da Vinci SP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Oct 2022to 5 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >20 and <75 years-old
- Willing and able to provide informed consent
- ASA≤ 3
- The subject is undergoing the following procedures
- diagnosis with of clinical stage I lung cancer
- The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus
- Preoperative platelet count 150-400 (1000/ uL)
Who cannot join
- Congestive heart failure (NHYA > II)
- Subjects with a known bleeding or clotting disorder
- Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation
- Subjects under immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery
- Subjects with pulmonary hypertension
- In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty)
Show all 15Show fewer
- Previous ipsilateral thoracic surgery or sternotomy
- Uncontrolled illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Previous neoadjuvant medical and/or radiation therapy
- Subject has a contraindication for general anesthesia or surgery
- Life expectancy < 6 months
- Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
- Subjects belong to vulnerable population (e.g., pregnancy or breastfeeding)
- International normalized ratio, INR >1.4
- Activated Partial Thromboplastin Time , APTT >35 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection
This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform
Read the detailed description
During the past several years, minimally invasive thoracic surgery has evolved from thoracoscopic approaches using 3 -4 ports to a single incision video-assisted thoracoscopic surgery (VATS) techniques. Recently, the experience acquired with the uniportal VATS technique through the intercostal space has allowed the development of a uniportal VATS subxiphoid or subcostal approach for major pulmonary resections. The advantage of using a subxiphoid or subcostal entry is to reduce pain by avoiding possible trauma of intercostal nerves caused by thoracic incisions. However, the longer distance from the subxiphoid or subcostal incision to the hilum makes this approach more difficult to perform anatomical pulmonary resections.During this same period of evolution into uniportal VATS surgery, robotic thoracic surgery has gained popularity as an alternative to traditional VATS. The advantages of robotics are the ability to perform surgery more precisely with articulated or wristed instruments, motion scaling, and tremor filtration, as well as improved visualization thanks to 3D high-definition video. However, currently 4 -5 incisions are still necessary to perform anatomic robotic resections.Recently, there has been a convergence of these two trends-uniportal surgery and robotic-assisted surgery-and has resulted in a single port robotic system, the da Vinci SP by Intuitive Surgical Cooperation. For this new platform, investigators plan to practice in thoracic anatomic lung resection
- Conditions
- Robotic Surgical Procedure
- Being tested
- Lung Anatomic Resection (Da Vinci SP)
- Keywords
- Early Stage Lung Cancer, Da Vinci SP, Robotic Thoracic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Anatomic Resection (Da Vinci SP)Device
To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection
| Study group | Role | What they receive |
|---|---|---|
| Da Vinci SP intervnetion group | Experimental | for patients who received Da Vinci SP robotic surgery Receives: Device: Lung Anatomic Resection (Da Vinci SP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of conversion rate
The primary performance endpoint will be assessed as the ability to successfully complete the planned anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.
Measured: During Surgery
Secondary outcomes (6)
Incidence of Treatment Related Adverse Events
The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur within the study follow-up period. Complications are assessed using the Common Terminology Criteria for Adverse Events, CTCAE.
Measured: One Year
Peri-operative parameters
Operation time (minute), docking time (minute), console time(minute), anesthesia time(minute), Time from recovery room to ward (minute)
Measured: From Surgery to ward,2- day
Peri-operative parameters: blood loss related
which include bloods loss(ml) during operation, blood transfusion (ml) during surgery
Measured: During surgery
Hospitalization parameters
which include, length of hospital stay (day)
Measured: During Hospitalization, an average of 4 days
Operative related complications during hospitalization
which include in-hospital mortality and morbidity, reasons need for reoperation, unplanned procedure after surgery
Measured: During Hospitalization, an average of 4 days
Patient disposition immediately after surgery
ICU, ward
Measured: During Hospitalization, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start7 Oct 2022
- Primary completion5 May 2024 (estimated)
- Study completion5 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robotic Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Model description
- clinical lung cancer who receive Da Vinci sp robotic surgery
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin Kai Chao, MD,PHD, Principal investigator, CHENG GUNG MEMORIAL HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535712
- Sponsor's protocol ID
- 202101423A0
- Status last verified
- Oct 2023
- First submitted
- 7 Jun 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng C, Tagkalos E, Ng CB, Hsu YC, Huang YY, Wu CF, Chao YK. Subcostal uniportal robotic anatomic lung resection: A pilot trial. JTCVS Tech. 2024 Apr 28;25:160-169. doi: 10.1016/j.xjtc.2024.01.024. eCollection 2024 Jun.
PubMed 38899114
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection
- ClinicalTrials.gov ID
- NCT05535712
- Acronym / sponsor ID
- 202101423A0
- Conditions
- Robotic Surgical Procedure
- Keywords
- Early Stage Lung Cancer, Da Vinci SP, Robotic Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 5 May 2024 (estimated)
- Study completion
- 5 May 2024 (estimated)
- First posted
- 10 Sep 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 is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform
Detailed description
During the past several years, minimally invasive thoracic surgery has evolved from thoracoscopic approaches using 3 -4 ports to a single incision video-assisted thoracoscopic surgery (VATS) techniques. Recently, the experience acquired with the uniportal VATS technique through the intercostal space has allowed the development of a uniportal VATS subxiphoid or subcostal approach for major pulmonary resections. The advantage of using a subxiphoid or subcostal entry is to reduce pain by avoiding possible trauma of intercostal nerves caused by thoracic incisions. However, the longer distance from the subxiphoid or subcostal incision to the hilum makes this approach more difficult to perform anatomical pulmonary resections.During this same period of evolution into uniportal VATS surgery, robotic thoracic surgery has gained popularity as an alternative to traditional VATS. The advantages of robotics are the ability to perform surgery more precisely with articulated or wristed instruments, motion scaling, and tremor filtration, as well as improved visualization thanks to 3D high-definition video. However, currently 4 -5 incisions are still necessary to perform anatomic robotic resections.Recently, there has been a convergence of these two trends-uniportal surgery and robotic-assisted surgery-and has resulted in a single port robotic system, the da Vinci SP by Intuitive Surgical Cooperation. For this new platform, investigators plan to practice in thoracic anatomic lung resection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- clinical lung cancer who receive Da Vinci sp robotic surgery
| Arm | Type | Receives |
|---|---|---|
| Da Vinci SP intervnetion group | Experimental | Device: Lung Anatomic Resection (Da Vinci SP)for patients who received Da Vinci SP robotic surgery |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >20 and <75 years-old
- Willing and able to provide informed consent
- ASA≤ 3
- The subject is undergoing the following procedures
- Preoperative platelet count 150-400 (1000/ uL)
Key exclusion criteria (15 listed)
- Congestive heart failure (NHYA > II)
- Subjects with a known bleeding or clotting disorder
- Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation
- Subjects under immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery
- Subjects with pulmonary hypertension
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 |
|---|---|---|
| Lung Anatomic Resection (Da Vinci SP)To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection | Device | Da Vinci SP intervnetion group |
Primary outcome
Incidence of conversion rate
Time frame: During Surgery
The primary performance endpoint will be assessed as the ability to successfully complete the planned anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.
6 secondary outcomes
Incidence of Treatment Related Adverse Events
Time frame: One Year
Peri-operative parameters
Time frame: From Surgery to ward,2- day
Peri-operative parameters: blood loss related
Time frame: During surgery
Hospitalization parameters
Time frame: During Hospitalization, an average of 4 days
Operative related complications during hospitalization
Time frame: During Hospitalization, an average of 4 days
Patient disposition immediately after surgery
Time frame: During Hospitalization, an average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 38899114Cheng C, Tagkalos E, Ng CB, Hsu YC, Huang YY, Wu CF, Chao YK. Subcostal uniportal robotic anatomic lung resection: A pilot trial. JTCVS Tech. 2024 Apr 28;25:160-169. doi: 10.1016/j.xjtc.2024.01.024. eCollection 2024 Jun.
- 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.
Yin Kai Chao, MD,PHD principal investigator
CHENG GUNG MEMORIAL 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 Lung Anatomic Resection (Da Vinci SP) in people with Robotic Surgical Procedure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 inclusion and 15 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 31 Oct 2023. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of conversion rate (time frame: During Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535712, which also lists 1 linked publication.
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 31 Oct 2023.