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出境医 / 临床实验 / Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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
Actual Study Start Date : June 12, 2019
Actual Primary Completion Date : September 16, 2019
Actual Study Completion Date : September 16, 2019
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
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Hong Kong
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
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
Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE June 12, 2019
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Safety: Incidence of Intra-Operative and Post-Operative Adverse Events [ Time Frame: 10 Days ]
    Number of Adverse Events
  • Feasibility: Caecal Intubation Rate (CIR) [ Time Frame: 1 Hour ]
    CIR: Number of Times Caecum is Reached
  • Feasibility: Time-to-Caecum (TTC) [ Time Frame: 1 Hour ]
    TTC: Time to Reach Caecum
  • Feasibility: Polyp Detection Rate (PDR) [ Time Frame: 1 Hour ]
    PDR: Number of Polyps Detected
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		Usability [ Time Frame: Day 1 (Day of Procedure) ]
Feedback on General Usage of the NISInspire-C Disposable Colonoscope
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 6, 2019) 		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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of a Novel Single Use Robotic Colonoscopy System
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Colonic Polyp
  • Colon Adenoma
  • Colorectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Subjects Receiving Colonoscopy
Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy
Intervention: Device: NISInspire-C System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 16, 2019
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979690
Other Study ID Numbers  ICMJE NISInspire-001
HKUCTR-2616 ( Registry Identifier: HKU Clinical Trials Registry (HKUCTR) )
HKUCTR-2617 ( Other Identifier: HKU Clinical Trials Registry (HKUCTR) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bio-Medical Engineering (HK) Limited
Study Sponsor  ICMJE Bio-Medical Engineering (HK) Limited
Collaborators  ICMJE The University of Hong Kong
Investigators  ICMJE
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
PRS Account Bio-Medical Engineering (HK) Limited
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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