An interventional study of Robotic-assisted Surgery in Thymoma, Mediastinal Tumor and Gynecologic Disease, sponsored by Intuitive Surgical. Active, not recruiting at 4 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Intuitive Surgical · Not applicable, Interventional, and Other
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.
133 studies on the registry are indexed under Thymoma; 37 are open to participants now.
This study's enrollment of 53 is above the median of 44 across 108 interventional studies indexed under Thymoma.
Browse Thymoma studies →Intuitive Surgical is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pre-operative Inclusion Criteria:
Pre-operative Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects scheduled to undergo robotic-assisted surgery
Device: Robotic-assisted Surgery
Subjects scheduled to undergo robotic-assisted surgery
Incidence of conversion
Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.
Time frame: Intra-operative
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.
Time frame: 30-day follow-up
Ran from Dec 2022 to primary completion in May 2023, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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