Feasibility Study of a Novel Single Use Robotic Colonoscopy System

NCT03979690 | Completed DMC

• 3 other identifiers: NISInspire-001HKUCTR-2616HKUCTR-2617
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single centre, non-randomized, tandem colonoscopy trial of the NISInspire-C System, followed immediately by a conventional colonoscope (CC). Each trial subject will undergo colonoscopy using the NISInspire-C system, followed immediately by CC. The purpose of this study is to obtain observational data on the safety profile, feasibility and usability of the NISInspire-C System in performing diagnostic colonoscopy in human subjects. The level of procedural pain experienced by subjects will also be explored.

Conditions

Colonic Polyp; Colon Adenoma; Colorectal Cancer

Keywords

Robotic Colonoscopy; Tandem Colonoscopy; NISInspire-C System; Single Use Colonoscope; Colonoscopy

Outcome Measures

Primary Outcomes (4)

• Safety: Incidence of Intra-Operative and Post-Operative Adverse Events

  Number of Adverse Events

  10 Days

• Feasibility: Caecal Intubation Rate (CIR)

  CIR: Number of Times Caecum is Reached

  1 Hour

• Feasibility: Time-to-Caecum (TTC)

  TTC: Time to Reach Caecum

  1 Hour

• Feasibility: Polyp Detection Rate (PDR)

  PDR: Number of Polyps Detected

  1 Hour

Secondary Outcomes (1)

• Usability

  Day 1 (Day of Procedure)

Other Outcomes (1)

• Intra-Procedural Pain (Exploratory Outcome)

  Day 1 (Day of Procedure)

Study Arms (1)

Subjects Receiving Colonoscopy

EXPERIMENTAL

Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy

Device: NISInspire-C System

Interventions

NISInspire-C System DEVICE

The NISInspire-C System is a disposable robotic colonoscopy system that consists of a flexible slender insertion tube designed to ensure non-invasive, reliable and safe colorectal screening. It comprises of two components: NISInspire-C Console, and the NISInspire-C Disposable Colonoscope.

Subjects Receiving Colonoscopy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Males Aged between 40 and 70 years; Females Aged between 55 and 70 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged between 40 and 70 years, inclusive, at the time of informed consent
• Females aged between 55 and 70 years, inclusive, at the time of informed consent (Rationale: to include only women with non-childbearing potential to avoid completely pregnant trial subjects)
• Symptomatic adults indicated for elective colonoscopy, or asymptomatic adults willing to undergo a colonoscopic screening for polyps or colorectal cancer
• Adults without prior colonoscopy
• Able to provide a written informed consent form approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study-specific procedures
• Willing and able to comply with the study procedures

You may not qualify if:

• History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, familial polyposis coli, hereditary nonpolyposis colorectal cancer syndrome, active diverticulitis or toxic megacolon
• Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
• Known bleeding tendency
• Received antiplatelet or anticoagulation therapy within 3 days prior to the colonoscopy day
• Known colonic stricture
• Known multiple sigmoid colon diverticula
• History of any abdominal or pelvis surgical procedures including colonic and rectal surgical resection
• Known abdominal wall hernias
• History of radiotherapy to the abdomen or pelvis
• Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy day
• Contraindication to the proposed anaesthesia
• Received any investigational medicine or treatment within 28 days prior to Screening
• Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study

Sponsors & Collaborators

• Bio-Medical Engineering (HK) Limited: lead
• The University of Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Wai Keung Leung, Professor

  Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

• Dominic Chi Chung Foo, Dr

  Division of Colorectal Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 7, 2019
• Study Start: June 12, 2019
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

HK (1)