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NCT04703829Active, not recruiting

Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy

Virtual Incision Robotically Assisted Surgical Device (VI RASD) for Umbrella Surgical Procedures: Minimally Invasive Right and Left Colectomy

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
30 (actual)
First submitted
9 Dec 2020
Start date
9 Aug 2021
Primary completion date
15 Feb 2023
Lead sponsor
Virtual Incision Corporation
NCT number
NCT04703829

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 9 Aug 2021 to the primary completion date, 15 Feb 2023
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has polyps that can be completely removed with negative surgical margins by colonoscopy.
  • Has had major surgery within 30 days prior to study enrollment or is scheduled to have major surgery within 30 days

Other illness

  • Has Stage T4 cancer diagnosis
  • History of abdominal adhesions or bowel obstruction
  • End stage renal disease
  • Active infection or has a history of local or systemic infection within 30 days of study screening
  • 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

Lab values

  • Hemoglobin \< 8.0

Age

  • Under the age of 22 or greater than the age of 85 years

Other

  • Subject unable or unwilling to provide informed consent
  • BMI of \< 19.5 and \> 45 kg/m2
  • Heights \< 60 inches
  • ASA grades IV-VI
  • Liver Cirrhosis
  • Women who are pregnant or lactating
  • Has participated or is participating in another clinical study which may confound study results
  • Not currently coagulopathic

Who the study is looking for

  • 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

Age in the registry: 22 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bryan Medical Center
Coordinator of this site? Confirm its status
LincolnUnited StatesUnknown status
Roper Saint Francis Mount Pleasant
Coordinator of this site? Confirm its status
Mt. PleasantUnited StatesUnknown status
Lankeanu Medical Center
Coordinator of this site? Confirm its status
WynnewoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.