Colon CancerNCT04703829
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
A study testing VI-RASD use in minimally invasive right or left colectomy and Right or Left colectomy in people with Colon Cancer and Colon Polyp, run by Virtual Incision Corporation at 3 sites in United States.
Trial summary
For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon. Both conventional laparoscopic and robotically assisted minimally invasive surgery have been shown to have reduced complication rates and shorter hospital stays. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Colon Cancer, Colon Polyp, Diverticular Diseases
- What is being tested?
- VI-RASD use in minimally invasive right or left colectomy and Right or Left colectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Aug 2021to Jan 2028
- Phase
- Interventional
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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to provide informed consent
- 22-85 years of age
- No history of frozen abdomen due to abdominal adhesions or multiple previous bowel obstructions
- Body mass index (BMI) between 19.5- 45 kg/m2
- A weight of at least 100 lbs. (45.36 kg.).
- Height of at least 60 inches (152 cm)
- ASA grades I through III
- Available for required postoperative follow up visits at 14 days and 30 days
Who cannot join
- Subject unable or unwilling to provide informed consent
- Under the age of 22 or greater than the age of 85 years
- Has polyps that can be completely removed with negative surgical margins by colonoscopy.
- Has Stage T4 cancer diagnosis
- History of abdominal adhesions or bowel obstruction
- BMI of < 19.5 and > 45 kg/m2
Show all 17Show fewer
- Heights < 60 inches
- ASA grades IV-VI
- End stage renal disease
- Liver Cirrhosis
- Women who are pregnant or lactating
- Active infection or has a history of local or systemic infection within 30 days of study screening
- Has had major surgery within 30 days prior to study enrollment or is scheduled to have major surgery within 30 days
- Has participated or is participating in another clinical study which may confound study results
- In the opinion of the Investigator, patient is not likely to comply with the required protocol activities; or, has a medical condition that should exclude the patient from the study
- Hemoglobin < 8.0
- Not currently coagulopathic
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bryan Medical Center
Lincoln, Nebraska, 68506
Roper Saint Francis Mount Pleasant
Mt. Pleasant, South Carolina, 29466
Lankeanu Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: Virtual Incision Robotically Assisted Surgical Device (VI RASD) for Umbrella Surgical Procedures: Minimally Invasive Right and Left Colectomy
For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon. Both conventional laparoscopic and robotically assisted minimally invasive surgery have been shown to have reduced complication rates and shorter hospital stays.
This study aims to look at the use of the VI RASD as a robotic surgical device in right or left colectomy procedures to see if the device performs as intended and is safe for use.
Read the detailed description
The purpose of the clinical study is to evaluate the device's indications for use in the clinical environment. The VI RASD is a surgical tool intended to assist in the endoscopic manipulation of tissue during bowel resections. The VI RASD is designed to allow a surgeon to perform minimally invasive colon procedures in the same fashion used in laproscopic and robotically assisted surgery with a single incision site in the abdominal wall.
The study will evaluate the efficacy of the VI RASD in manipulating and dissecting the right or left colon and preparing the colon for resection. The safety profile of the device will also be assessed through analysis of overall intraoperative and post operative adverse events as compared to published literature.
- Being tested
- VI-RASD use in minimally invasive right or left colectomy, Right or Left colectomy
- Keywords
- Colectomy
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps, Diverticular Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VI-RASD use in minimally invasive right or left colectomyDevice
Virtual Incision Corp, VI-RASD use in right or left colectomy procedures.
Right or Left colectomyProcedure or surgery
Surgical Procedures in which the VI RASD will be used.
| Study group | Role | What they receive |
|---|---|---|
| VI-RASD | Experimental | Use of VI RASD in right or left colectomy procedures Receives: Device: VI-RASD use in minimally invasive right or left colectomy; Procedure: Right or Left colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Number of Participants With Successful Completion of the VI RASD Steps in Colectomy Procedures Without Conversion to Open Surgery
Count and calculated percentage of enrolled subjects in which the VI RASD steps were successfully completed and did not require conversion to open surgery.
VI RASD steps include: the VI-RASD system is inserted and deployed to corresponding abdominal cavity, used to manipulate and dissect the colon allowing for transection of the colon and small bowel, and system is removed from the abdominal cavity.
Measured: Intraoperative Period- Surgical Procedure Start time to Surgical Procedure End time
Determine the Safety Profile of VI-RASD as the Number of Enrolled Subjects Experiencing Either an Intraoperative and/or Postoperative Adverse Events Occurring Within 30 Days Post Procedure.
Count and calculated percentage of enrolled subjects experiencing an intraoperative and/or postoperative adverse events.
Measured: Time insertion of the VI RASD device is initiated (intraoperative) through 30 days (+/- 5 days) post procedure (post operative).
Secondary outcomes (11)
Clinical Outcome Measure- Length of Stay (Number of Days)
Median number of days for the VI-RASD arm calculated from Date of Procedure (Day 0) to Date of Discharge.
Measured: Calculated in number of days from date of procedure through date of discharge
Clinical Outcome Measures-Number of Subjects With Reported Intraoperative Adverse Event
Comparison of number/calculated percentage of enrolled subjects experiencing an intraoperative adverse event.
Measured: Intraoperative-Procedure start time to Procedure end time
Clinical Outcome Measure- Number of Participants Requiring Conversion to Open Surgery
Count and calculated percentage of enrolled subjects requiring conversion to open surgery.
Measured: Intraoperative: Procedure start time to Procedure end time
Clinical Outcome Measure-Median Operative Time for All Enrolled Participants.
Median time(all enrolled participants) in minutes elapsed between procedure start and stop time.
Measured: Intraoperative: Procedure Start Time to Procedure End Time
Clinical Outcome Measure-Number of Subjects With Reported Post Operative Complications Related to Study Device and/or Procedure.
Comparison of Number/Calculated percentage of participants with a reported adverse event related to the study device and/or procedure that occurred post operatively thru the 30 day post procedure visit.
Measured: Procedure end time thru 30 day post procedure visit
Clinical Outcome Measure-Re-admission Rate: Number of Participants Readmitted to Hospital
Number/calculated percentage of participants readmitted to the hospital after discharge from study procedure for any reason.
Measured: From date of discharge thru 30 days post procedure
Clinical Outcome Measure- Re Encounter Rates-Number of Participants Requiring an Unplanned Visit.
Number/Calculated Percentage of participants requiring an unplanned follow up visit for a potential complication related to procedure. Unplanned visit defined as either a phone call with medical provider or a visit to a medical provider.
Measured: From date of discharge thru 30 days post procedure
Clinical Outcome Measure-Reoperation Rate: Number of Participants Requiring Reoperation
Total number/calculated percentage of subjects requiring any additional operation related to the underlying medical condition. This number is compared to Published literature Zawadski PMID 31481637
Measured: From date of procedure thru 30 day post procedure.
Clinical Outcome Measure-Reoccurrence Rate: Number of Participants With Recurrence of Disease
Number of subjects reporting recurrence of underlying medical condition/indication for for colectomy procedure. No comparative data is available in published literature referenced in the study.
Measured: From date of procedure thru 30 days post procedure.
Clinical Outcome Measure- Mortality: Number of Deaths Reported
Number and calculated percentage of all cause deaths.
Measured: From date of procedure through 30 day post procedure
Clinical Outcome Measure- Number of Additional Laparoscopic Ports Used, Including Reason for Use.
Number of additional laparoscopic ports used during procedure was collected. Reason for additional port also captured.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start9 Aug 2021
- Primary completion15 Feb 2023
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virtual Incision Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitry Oleynikov, M.D., Study chair, Virtual Incision Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703829
- Sponsor's protocol ID
- 110-000122
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2020
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Marks JH, Keller DS, Lagares-Garcia JA, Schoonyoung HP, Farritor SM, Oleynikov D, Jobst MA. Safety and Efficacy of a Novel Miniaturized Robotic-Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework. Dis Colon Rectum. 2024 Aug 1;67(8):1085-1093. doi: 10.1097/DCR.0000000000003249. Epub 2024 Jul 13.
PubMed 38653496