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To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
Primary Performance:
The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion* to an alternate approach comprises conversion to open, multiport laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.
Primary Safety:
• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP Lower Anterior Resection | Other | Lower anterior resections (LAR) procedures will performed by da Vinci SP® Surgical System |
|
| SP Right Colectomy | Other | Right Colectomy (RC) procedures performed by da Vinci SP® Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Assisted Surgery | Device | da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Conversion | Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. | IntraOperative period |
| Major Adverse Events Rates | Safety defined as the incidence of all major adverse events that occur through the 42-day follow-up period | Intraoperative through the 42-day postoperative period |
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Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criteria:
• Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure
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| Name | Affiliation | Role |
|---|---|---|
| Madhu L Gorrepati | Clinical Affairs Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adventist Health System/Sunbelt | Orlando | Florida | 32803 | United States | ||
| Henry Ford |
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| ID | Title | Description |
|---|---|---|
| FG000 | SP Colorectal Procedure - Right Colectomy (RC) | Right Colectomy procedures performed by da Vinci SP® Surgical System |
| FG001 | SP Colorectal Procedures - Lower Anterior Resection (LAR) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2023 |
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| Detroit |
| Michigan |
| 48202 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| MountianView Hospital | Las Vegas | Nevada | 89128 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| MultiCare - Tacoma | Tacoma | Washington | 98405 | United States |
| Ulsan University Hospital | Ulsan | Dong-gu | 25 Daehakbyeongwon-ro | South Korea |
| Ewha Womans University College of Medicine | Seoul | Gangseo-gu | Gonghang-daero | South Korea |
Lower Anterior Resection performed by the da Vinci SP
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SP Colorectal Procedure - Right Colectomy (RC) | Right Colectomy procedures performed by da Vinci SP® Surgical System |
| BG001 | SP Colorectal Procedures - Lower Anterior Resection (LAR) | Lower Anterior Resection performed by the da Vinci SP |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Right Colectomy and Lower Anterior Resection groups were analyzed separately, including analysis for Age. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Conversion | Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. | Posted | Count of Participants | Participants | IntraOperative period |
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| Primary | Major Adverse Events Rates | Safety defined as the incidence of all major adverse events that occur through the 42-day follow-up period | Posted | Count of Participants | Participants | Intraoperative through the 42-day postoperative period |
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Through the 42 day postoperative period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SP Colorectal - Right Colectomy (RC) | Right Colectomy procedures performed by da Vinci SP® Surgical System | 0 | 28 | 2 | 28 | 1 | 28 |
| EG001 | SP Colorectal - Lower Anterior Resection (LAR) | Lower anterior resection procedures performed by da Vinci SP® Surgical System | 0 | 29 | 5 | 29 | 0 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hematoma | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Anastomotic Dehiscence | Gastrointestinal disorders | Systematic Assessment |
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| Dehydration | Renal and urinary disorders | Systematic Assessment |
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| High Ileostomy Output | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Adverse Event | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intraoperative Adverse Event | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Shelley | Intuitive | 1 707 369 4217 | SP-CR@intusurg.com |
| Apr 14, 2026 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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| Lower Anterior Resection (LAR) |
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| United States |
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