Trial Outcomes & Findings for SP Thoracic IDE Study (NCT NCT05150210)

NCT ID: NCT05150210

Last Updated: 2025-12-23

Results Overview

Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: Intra-operative period
• Results posted on: 2025-12-23

Participant Flow

Participant milestones

Measure	SP Surgical System -Thymectomy Thymectomy procedures performed by da Vinci SP Surgical System.	SP Surgical System - Lobectomy Lobectomy procedures performed by the SP Surgical System
Overall Study STARTED	13	19
Overall Study COMPLETED	13	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thymectomy and Lobectomy groups were analyzed separately, including analysis for Age.

Baseline characteristics by cohort

Measure	SP Surgical System - Thymectomy n=13 Participants Pulmonary thymectomy procedures performed by da Vinci SP Surgical System.	SP Surgical System - Lobectomy n=19 Participants Pulmonary lobectomy procedures performed by da Vinci SP Surgical System.	Total n=32 Participants Total of all reporting groups
Age, Continuous Thymectomy	54.5 years STANDARD_DEVIATION 15.86 • n=13 Participants • Thymectomy and Lobectomy groups were analyzed separately, including analysis for Age.	—	54.5 years STANDARD_DEVIATION 15.86 • n=13 Participants • Thymectomy and Lobectomy groups were analyzed separately, including analysis for Age.
Age, Continuous Lobectomy	—	66.4 years STANDARD_DEVIATION 8.06 • n=19 Participants • Thymectomy and Lobectomy groups were analyzed separately, including analysis for Age.	66.4 years STANDARD_DEVIATION 8.06 • n=19 Participants • Thymectomy and Lobectomy groups were analyzed separately, including analysis for Age.
Sex: Female, Male Female	11 Participants n=13 Participants	6 Participants n=19 Participants	17 Participants n=32 Participants
Sex: Female, Male Male	2 Participants n=13 Participants	13 Participants n=19 Participants	15 Participants n=32 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=19 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Asian	3 Participants n=13 Participants	6 Participants n=19 Participants	9 Participants n=32 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=19 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Black or African American	2 Participants n=13 Participants	0 Participants n=19 Participants	2 Participants n=32 Participants
Race (NIH/OMB) White	7 Participants n=13 Participants	12 Participants n=19 Participants	19 Participants n=32 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=19 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants	1 Participants n=19 Participants	2 Participants n=32 Participants

PRIMARY outcome

Timeframe: Intra-operative period

Population: 0 Conversions occured

Performance defined as the ability to complete the planned da Vinci SP-assisted pulmonary lobectomy and thymectomy procedures without conversion to an alternate approach

Outcome measures

Measure	SP Surgical System- Thymectomy Arm n=13 Participants Thymectomy procedures performed by da Vinci SP Surgical System.	SP Surgical System - Lobectomy Arm n=19 Participants Lobectomy procedures performed by the da Vinci SP Surgical System.
Rate of Conversion	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Intra-operative through the 30 days follow-up period

Safety defined as the incidence of major intra-operative and post-operative adverse events that occur through the 30-day follow-up period.

Outcome measures

Measure	SP Surgical System- Thymectomy Arm n=13 Participants Thymectomy procedures performed by da Vinci SP Surgical System.	SP Surgical System - Lobectomy Arm n=19 Participants Lobectomy procedures performed by the da Vinci SP Surgical System.
Major Adverse Event Rate	0 Participants	3 Participants

Adverse Events

SP Surgical System- Thymectomy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

SP Surgical System- Pulmonary Lobectomy

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	SP Surgical System- Thymectomy n=32 participants at risk；n=13 participants at risk Thymectomy procedures performed by da Vinci SP Surgical System.	SP Surgical System- Pulmonary Lobectomy n=19 participants at risk Pulmonary lobectomy procedures performed by da Vinci SP Surgical System.
Respiratory, thoracic and mediastinal disorders Air Leakage	0.00% 0/13 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher	15.8% 3/19 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/13 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher	5.3% 1/19 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher

Other adverse events

Measure	SP Surgical System- Thymectomy n=32 participants at risk；n=13 participants at risk Thymectomy procedures performed by da Vinci SP Surgical System.	SP Surgical System- Pulmonary Lobectomy n=19 participants at risk Pulmonary lobectomy procedures performed by da Vinci SP Surgical System.
Respiratory, thoracic and mediastinal disorders Intraoperative Adverse Event	0.00% 0/32 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher	0.00% 0/19 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher
General disorders Non-serious AE	15.6% 5/32 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher	26.3% 5/19 • Through the 30 day follow up period. Major adverse events: Clavien-Dindo Grade III or higher

Additional Information

Anna Virk

Intuitive

Phone: 1 480-676-3938

Email: SP.Thoracic@intusurg.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place