Robotic Surgical ProcedureNCT05455840
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease
A study testing Da Vinci SP surgical platform in people with Robotic Surgical Procedure and Thymoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Endpoints (Outcome measures)： 1. Primary endpoint: Incidence of conversion rate during surgery The primary performance endpoint will be assessed as the ability to successfully complete the planned mediastinal procedure with da Vinci SP System, with no conversion to open surgery, video-assisted thoracoscopic surgery… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Robotic Surgical Procedure, Thymoma, Myasthenia Gravis
- What is being tested?
- Da Vinci SP surgical platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2022to 11 Apr 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 fulfills one or both of the following criteria:
- Diagnosis of myasthenia gravis
- Masaoka stage I or II thymoma; thymic mass ≤ 5 cm diameter
Show all 21Show fewer
- Class I-IV Myasthenia gravis according to the Myasthenia Gravis Foundation of America Scientific Session (MGFA)
- Exclusion criteria. Myasthenia gravis or thymoma patients with
- Congestive heart failure (NHYA > II)
- Arrhythmia required medication control
- 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 within 30 days prior to the planned surgery
- 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
- Uncontrolled myasthenia gravis symptoms at the time of scheduled surgery
- Confirmed thymic carcinoma
- Patients who are not suitable for performing endoscopic surgery.
- Myasthenia gravis patients with positive serum MuSK antibody. -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Endpoints (Outcome measures)：
- Primary endpoint: Incidence of conversion rate during surgery
Read more
- The primary performance endpoint will be assessed as the ability to successfully complete the planned mediastinal procedure with da Vinci SP System, with no conversion to open surgery, video-assisted thoracoscopic surgery (VATS), multi-port robotic surgery or approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. Use of additional assistant port(s) is not considered a conversion
- Secondary endpoints: Incidence of treatment related adverse events - The safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow up period
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 anterior mediastinal tumor 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 anterior mediastinal area makes this approach more difficult to perform extended thymothymectomy. 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 extended thymothymectomy
- Conditions
- Robotic Surgical Procedure, Thymoma, Myasthenia Gravis
- Being tested
- Da Vinci SP surgical platform
- Keywords
- single incision robotic minimal invasive surgery, robotic mediastinal tumor resection, da Vinci SP® surgical system
- Medical subject headings
- Thymoma, Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da Vinci SP surgical platformDevice
using Da Vinci SP platform in thymothymectomy or extended thymectomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients with qualified criteria will be enrolled in this study Receives: Device: Da Vinci SP surgical platform |
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 procedure with da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery.
Measured: During Surgery
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
The safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow up period. Rceord the Incidence of Treatment-Emergent Adverse Events in our recording form
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start3 Aug 2022
- Primary completion11 Apr 2024 (estimated)
- Study completion11 Apr 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
- thymothmectomy or extended thymectomy through Da Vinci SP platform
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
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
- NCT05455840
- Sponsor's protocol ID
- 202101422A0
- Status last verified
- Oct 2023
- First submitted
- 16 May 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, Wen YW, Chien MS, Chao YK. Chronic Neuralgia After Single-Port Versus Multiport Trans-Subxiphoid Robotic Mediastinal Surgery: A Prospective Single-Arm Pilot Study With Historical Controls. Int J Med Robot. 2026 Apr;22(2):e70158. doi: 10.1002/rcs.70158.
PubMed 41923497
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
- A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease
- ClinicalTrials.gov ID
- NCT05455840
- Acronym / sponsor ID
- 202101422A0
- Conditions
- Robotic Surgical Procedure, Thymoma, Myasthenia Gravis
- Keywords
- single incision robotic minimal invasive surgery, robotic mediastinal tumor resection, da Vinci SP® surgical system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 11 Apr 2024 (estimated)
- Study completion
- 11 Apr 2024 (estimated)
- First posted
- 13 Jul 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.
Endpoints (Outcome measures)：
- Primary endpoint: Incidence of conversion rate during surgery
- The primary performance endpoint will be assessed as the ability to successfully complete the planned mediastinal procedure with da Vinci SP System, with no conversion to open surgery, video-assisted thoracoscopic surgery (VATS), multi-port robotic surgery or approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. Use of additional assistant port(s) is not considered a conversion
- Secondary endpoints: Incidence of treatment related adverse events - The safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow up period
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 anterior mediastinal tumor 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 anterior mediastinal area makes this approach more difficult to perform extended thymothymectomy. 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 extended thymothymectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- thymothmectomy or extended thymectomy through Da Vinci SP platform
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Da Vinci SP surgical platformPatients with qualified criteria will be enrolled in this study |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age >20 and <75 years-old
- Willing and able to provide informed consent
- ASA≤ 3
- The subject fulfills one or both of the following criteria:
- Class I-IV Myasthenia gravis according to the Myasthenia Gravis Foundation of America Scientific Session (MGFA)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Da Vinci SP surgical platformusing Da Vinci SP platform in thymothymectomy or extended thymectomy | Device | Intervention |
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 procedure with da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: One year
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 41923497Cheng C, Wen YW, Chien MS, Chao YK. Chronic Neuralgia After Single-Port Versus Multiport Trans-Subxiphoid Robotic Mediastinal Surgery: A Prospective Single-Arm Pilot Study With Historical Controls. Int J Med Robot. 2026 Apr;22(2):e70158. doi: 10.1002/rcs.70158.
- 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 Da Vinci SP surgical platform in people with Robotic Surgical Procedure and Thymoma, 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 21 inclusion and 0 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 NCT05455840, 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.