Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy

Virtual Incision Corporation

Status

Active, not recruiting

Conditions

Diverticular Diseases

Colon Cancer

Colon Polyp

Inflammatory Bowel Diseases

Treatments

Procedure: Right or Left colectomy

Device: VI-RASD use in minimally invasive right or left colectomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04703829

110-000122

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

22 to 85 years old

Volunteers

No Healthy Volunteers

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