Trial Outcomes & Findings for da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures (NCT NCT04403022)
NCT ID: NCT04403022
Last Updated: 2026-06-03
Results Overview
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
IntraOperative period
Results posted on
2026-06-03
Participant Flow
Participant milestones
| Measure |
SP Colorectal Procedure - Right Colectomy (RC)
Right Colectomy procedures performed by da Vinci SP® Surgical System
|
SP Colorectal Procedures - Lower Anterior Resection (LAR)
Lower Anterior Resection performed by the da Vinci SP
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
SP Colorectal Procedure - Right Colectomy (RC)
Right Colectomy procedures performed by da Vinci SP® Surgical System
|
SP Colorectal Procedures - Lower Anterior Resection (LAR)
Lower Anterior Resection performed by the da Vinci SP
|
|---|---|---|
|
Overall Study
Other procedure completed
|
1
|
2
|
Baseline Characteristics
Right Colectomy and Lower Anterior Resection groups were analyzed separately, including analysis for Age.
Baseline characteristics by cohort
| Measure |
SP Colorectal Procedure - Right Colectomy (RC)
n=28 Participants
Right Colectomy procedures performed by da Vinci SP® Surgical System
|
SP Colorectal Procedures - Lower Anterior Resection (LAR)
n=29 Participants
Lower Anterior Resection performed by the da Vinci SP
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Right Colectomy (RC)
|
64.4 years
STANDARD_DEVIATION 13.45 • n=28 Participants • Right Colectomy and Lower Anterior Resection groups were analyzed separately, including analysis for Age.
|
—
|
64.4 years
STANDARD_DEVIATION 13.45 • n=28 Participants • Right Colectomy and Lower Anterior Resection groups were analyzed separately, including analysis for Age.
|
|
Age, Continuous
Lower Anterior Resection (LAR)
|
—
|
54.4 years
STANDARD_DEVIATION 12.71 • n=29 Participants • Right Colectomy and Lower Anterior Resection groups were analyzed separately, including analysis for Age.
|
54.4 years
STANDARD_DEVIATION 12.71 • n=29 Participants • Right Colectomy and Lower Anterior Resection groups were analyzed separately, including analysis for Age.
|
|
Sex: Female, Male
Female
|
16 Participants
n=28 Participants
|
12 Participants
n=29 Participants
|
28 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=28 Participants
|
17 Participants
n=29 Participants
|
29 Participants
n=57 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=28 Participants
|
11 Participants
n=29 Participants
|
21 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=28 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=57 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=28 Participants
|
17 Participants
n=29 Participants
|
34 Participants
n=57 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=57 Participants
|
|
Region of Enrollment
South Korea
|
10 participants
n=28 Participants
|
10 participants
n=29 Participants
|
20 participants
n=57 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=28 Participants
|
19 participants
n=29 Participants
|
37 participants
n=57 Participants
|
PRIMARY outcome
Timeframe: IntraOperative periodPerformance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
Outcome measures
| Measure |
SP Colorectal Procedure - Right Colectomy (RC)
n=28 Participants
Right Colectomy procedures performed by da Vinci SP® Surgical System
|
SP Colorectal Procedures - Lower Anterior Resection (LAR)
n=29 Participants
Lower Anterior Resection performed by the da Vinci SP
|
|---|---|---|
|
Rate of Conversion
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Intraoperative through the 42-day postoperative periodSafety defined as the incidence of all major adverse events that occur through the 42-day follow-up period
Outcome measures
| Measure |
SP Colorectal Procedure - Right Colectomy (RC)
n=28 Participants
Right Colectomy procedures performed by da Vinci SP® Surgical System
|
SP Colorectal Procedures - Lower Anterior Resection (LAR)
n=29 Participants
Lower Anterior Resection performed by the da Vinci SP
|
|---|---|---|
|
Major Adverse Events Rates
|
1 Participants
|
3 Participants
|
Adverse Events
SP Colorectal - Right Colectomy (RC)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
SP Colorectal - Lower Anterior Resection (LAR)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SP Colorectal - Right Colectomy (RC)
n=28 participants at risk
Right Colectomy procedures performed by da Vinci SP® Surgical System
|
SP Colorectal - Lower Anterior Resection (LAR)
n=29 participants at risk
Lower anterior resection procedures performed by da Vinci SP® Surgical System
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
3.6%
1/28 • Through the 42 day postoperative period
|
6.9%
2/29 • Through the 42 day postoperative period
|
|
Gastrointestinal disorders
Hematoma
|
0.00%
0/28 • Through the 42 day postoperative period
|
3.4%
1/29 • Through the 42 day postoperative period
|
|
Renal and urinary disorders
Acute Renal Failure
|
3.6%
1/28 • Through the 42 day postoperative period
|
3.4%
1/29 • Through the 42 day postoperative period
|
|
Gastrointestinal disorders
Anastomotic Dehiscence
|
0.00%
0/28 • Through the 42 day postoperative period
|
3.4%
1/29 • Through the 42 day postoperative period
|
|
Renal and urinary disorders
Dehydration
|
0.00%
0/28 • Through the 42 day postoperative period
|
3.4%
1/29 • Through the 42 day postoperative period
|
|
Gastrointestinal disorders
High Ileostomy Output
|
0.00%
0/28 • Through the 42 day postoperative period
|
3.4%
1/29 • Through the 42 day postoperative period
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/28 • Through the 42 day postoperative period
|
3.4%
1/29 • Through the 42 day postoperative period
|
Other adverse events
| Measure |
SP Colorectal - Right Colectomy (RC)
n=28 participants at risk
Right Colectomy procedures performed by da Vinci SP® Surgical System
|
SP Colorectal - Lower Anterior Resection (LAR)
n=29 participants at risk
Lower anterior resection procedures performed by da Vinci SP® Surgical System
|
|---|---|---|
|
Gastrointestinal disorders
Major Adverse Event
|
0.00%
0/28 • Through the 42 day postoperative period
|
0.00%
0/29 • Through the 42 day postoperative period
|
|
Gastrointestinal disorders
Intraoperative Adverse Event
|
3.6%
1/28 • Through the 42 day postoperative period
|
0.00%
0/29 • Through the 42 day postoperative period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place