VI-RASD use in minimally invasive right or left colectomyRight or Left colectomy
VI-RASD use in minimally invasive right or left colectomy: Virtual Incision Corp, VI-RASD use in right or left colectomy procedures.
Right or Left colectomy: Surgical Procedures in which the VI RASD will be used.
Study 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.
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Efficacy: Number of Participants With Successful Completion of the VI RASD Steps in Colectomy Procedures Without Conversion to Open Surgery — Intraoperative Period- Surgical Procedure Start time to Surgical Procedure End time 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.
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. — Time insertion of the VI RASD device is initiated (intraoperative) through 30 days (+/- 5 days) post procedure (post operative). Count and calculated percentage of enrolled subjects experiencing an intraoperative and/or postoperative adverse events.
Trial sites (3)
Facility
City
Region
Status
Bryan Medical Center
Lincoln
Nebraska
Lankeanu Medical Center
Wynnewood
Pennsylvania
Roper Saint Francis Mount Pleasant
Mt. Pleasant
South Carolina
More Virtual Incision Corporation trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
