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Feasibility Study of a Novel Single Use Robotic Colonoscopy System

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ClinicalTrials.gov Identifier: NCT03979690
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Bio-Medical Engineering (HK) Limited

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.

Condition or disease Intervention/treatment Phase
Colonic Polyp Colon Adenoma Colorectal Cancer Device: NISInspire-C System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Subjects Receiving Colonoscopy
Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy
Device: NISInspire-C System
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 Outcome Measures :
  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 Outcome Measures :
  1. Usability [ Time Frame: Day 1 (Day of Procedure) ]
    Feedback on General Usage of the NISInspire-C Disposable Colonoscope


Other Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males Aged between 40 and 70 years; Females Aged between 55 and 70 years
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979690


Contacts
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Contact: HKUCTR Administrator +852 2255 2548 hkuctreg@hku.hk

Locations
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Hong Kong
The University of Hong Kong, Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: HKUCTR Administrator    +852 2255 2548    hkuctreg@hku.hk   
Sponsors and Collaborators
Bio-Medical Engineering (HK) Limited
The University of Hong Kong
Investigators
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Principal Investigator: 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

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Responsible Party: Bio-Medical Engineering (HK) Limited
ClinicalTrials.gov Identifier: NCT03979690     History of Changes
Other Study ID Numbers: NISInspire-001
HKUCTR-2616 ( Registry Identifier: HKU Clinical Trials Registry (HKUCTR) )
HKUCTR-2617 ( Other Identifier: HKU Clinical Trials Registry (HKUCTR) )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bio-Medical Engineering (HK) Limited:
Robotic Colonoscopy
Tandem Colonoscopy
NISInspire-C System
Single Use Colonoscope
Colonoscopy

Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical