Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy

Official record

Identifier

NCT04703829

Recruiting locations

country

United States

Interventions studied

VI-RASD use in minimally invasive right or left colectomyRight or Left colectomy

Lead sponsor

Virtual Incision Corporation

Target enrolment

30 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Active, not recruiting

First posted

Jan 11, 2021

Last updated on the registry

Oct 1, 2026

Age

22 Years – 85 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Indexed under

Colorectal Cancer