ThymomaNCT05682742
Clinical Investigation of the da Vinci Surgical System
A study testing Robotic-assisted Surgery in people with Thymoma and Mediastinal Tumor, run by Intuitive Surgical at 4 sites in United States.
Trial summary
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Thymoma, Mediastinal Tumor, Gynecologic Disease
- What is being tested?
- Robotic-assisted Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Dec 2022to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Pre-operative Inclusion Criteria:
- Age 21 years or older
- Per study Investigator's discretion, subject is a suitable candidate to undergo multiport robotic-assisted surgery for the study specified procedure as a primary procedure
Pre-operative Exclusion Criteria:
- Subject is pregnant or suspected to be pregnant or breastfeeding
- Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data
- Subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months
- Subject belongs to vulnerable population.
- Subject is contraindicated for anesthesia or surgery
- Subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for treatment of the cancer to be resected within the past 6 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Sparrow Health System
Lansing, Michigan, 48912
Orlando Health, Inc.
Orlando, Florida, 32806
The Valley Hospital
Ridgewood, New Jersey, 07450
About this study
Official title: A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
- Conditions
- Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer, Pelvic Organ Prolapse, Prostate Disease
- Being tested
- Robotic-assisted Surgery
- Medical subject headings
- Thymoma, Mediastinal Neoplasms, Genital Diseases, Female, Pelvic Organ Prolapse, Prostatic Diseases, Prostatic Neoplasms, Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted SurgeryDevice
Subjects scheduled to undergo robotic-assisted surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted surgery | Experimental | Subjects scheduled to undergo robotic-assisted surgery Receives: Device: Robotic-assisted Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of conversion
Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.
Measured: Intra-operative
Secondary outcomes (1)
Incidence of adverse events
Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.
Measured: 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start12 Dec 2022
- Primary completion24 May 2023
- Study completion31 Aug 2028 (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 ThymomaStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682742
- Sponsor's protocol ID
- 1097341C
- Status last verified
- May 2024
- First submitted
- 22 Dec 2022
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Merritt RE, Teixeira A, Needleman B, Meara M, Cosgrove C, Sanchez AE, Herrera LJ, Kwasny L, Miller R, Bartley J, Qandeel H, Levy J, Culligan P. A prospective, nonrandomized clinical investigation of the da Vinci surgical system model IS5000. J Robot Surg. 2025 Oct 1;19(1):650. doi: 10.1007/s11701-025-02837-w.
PubMed 41032176
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System
- ClinicalTrials.gov ID
- NCT05682742
- Acronym / sponsor ID
- 1097341C
- Conditions
- Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer, Pelvic Organ Prolapse, Prostate Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 Jan 2023 (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 prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted surgery | Experimental | Device: Robotic-assisted SurgerySubjects scheduled to undergo robotic-assisted surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 SurgerySubjects scheduled to undergo robotic-assisted surgery | Device | Robotic-assisted surgery |
Primary outcome
Incidence of conversion
Time frame: Intra-operative
Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.
1 secondary outcome
Incidence of adverse events
Time frame: 30-day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Derived from this study: PubMed 41032176Merritt RE, Teixeira A, Needleman B, Meara M, Cosgrove C, Sanchez AE, Herrera LJ, Kwasny L, Miller R, Bartley J, Qandeel H, Levy J, Culligan P. A prospective, nonrandomized clinical investigation of the da Vinci surgical system model IS5000. J Robot Surg. 2025 Oct 1;19(1):650. doi: 10.1007/s11701-025-02837-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted Surgery in people with Thymoma and Mediastinal Tumor, run by Intuitive Surgical at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: Intra-operative). 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 NCT05682742, 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 3 Jun 2024.