Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy

NCT04703829 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 110-000122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colon Cancer; Colon Polyp; Inflammatory Bowel Diseases; Diverticular Diseases

Keywords

Colectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Calculated in number of days from date of procedure through date of discharge

• Clinical Outcome Measures-Number of Subjects With Reported Intraoperative Adverse Event

  Intraoperative-Procedure start time to Procedure end time

• Clinical Outcome Measure- Number of Participants Requiring Conversion to Open Surgery

  Intraoperative: Procedure start time to Procedure end time

• Clinical Outcome Measure-Median Operative Time for All Enrolled Participants.

  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.

  Procedure end time thru 30 day post procedure visit

Other Outcomes (1)

• Long Term Oncological Status

  Date of procedure through 5 years post procedure

Study Arms (1)

VI-RASD

EXPERIMENTAL

Use of VI RASD in right or left colectomy procedures

Device: VI-RASD use in minimally invasive right or left colectomy; Procedure: Right or Left colectomy

Interventions

VI-RASD use in minimally invasive right or left colectomy DEVICE

Virtual Incision Corp, VI-RASD use in right or left colectomy procedures.

VI-RASD

Right or Left colectomy PROCEDURE

Surgical Procedures in which the VI RASD will be used.

VI-RASD

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to provide informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virtual Incision Corporation: lead

Study Sites (3)

Bryan Medical Center

Lincoln, Nebraska, 68506, United States

Location

Lankeanu Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Roper Saint Francis Mount Pleasant

Mt. Pleasant, South Carolina, 29466, United States

Location

Related Publications (1)

• 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.

  PMID: 38653496 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps; Diverticular Diseases; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastroenteritis

Results Point of Contact

• Title: Florence Beck
• Organization: Virtual Incision Corporation

florence.beck@virtualincision.com

(352) 275-7267

Study Officials

• Dmitry Oleynikov, M.D.

  Virtual Incision Corp.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 11, 2021
• Study Start: August 9, 2021
• Primary Completion: February 15, 2023
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 1, 2026
• Results First Posted: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)