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OpenTrials
Completed

NCT Number: NCT03979690

Feasibility Study of a Novel Single Use Robotic Colonoscopy System

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Safety: Incidence of Intra-Operative and Post-Operative Adverse Events

    Time frame: 10 Days

    Number of Adverse Events

  2. Feasibility: Caecal Intubation Rate (CIR)

    Time frame: 1 Hour

    CIR: Number of Times Caecum is Reached

  3. Feasibility: Time-to-Caecum (TTC)

    Time frame: 1 Hour

    TTC: Time to Reach Caecum

  4. Feasibility: Polyp Detection Rate (PDR)

    Time frame: 1 Hour

    PDR: Number of Polyps Detected

Secondary outcomes

  1. Usability

    Time frame: Day 1 (Day of Procedure)

    Feedback on General Usage of the NISInspire-C Disposable Colonoscope

Other outcomes

  1. Intra-Procedural Pain (Exploratory Outcome)

    Time frame: Day 1 (Day of Procedure)

    The Level of Procedural Pain Experienced by Subjects Undergoing the Colonoscopy Procedures will be Explored.

Sponsors and collaborators

Lead sponsor

Bio-Medical Engineering (HK) Limited

Industry

Collaborators

  • The University of Hong Kong

Registry information

Official study title

A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Feasibility of Novel Single Use Robotic Colonoscopy System ("NISInspire-C System") in Human Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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