Clinical trial NCT03979690: Feasibility Study of a Novel Single Use Robotic Colonoscopy System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Colon Adenoma
Colorectal Cancer
Keywords: Robotic Colonoscopy
Tandem Colonoscopy
NISInspire-C System
Single Use Colonoscope
Colonoscopy
Lead sponsor: Bio-Medical Engineering (HK) Limited
Sponsor class: INDUSTRY
Collaborators: name: The University of Hong Kong
First posted: 2019-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Safety: Incidence of Intra-Operative and Post-Operative Adverse Events
timeFrame: 10 Days
measure: Feasibility: Caecal Intubation Rate (CIR)
timeFrame: 1 Hour
measure: Feasibility: Time-to-Caecum (TTC)
timeFrame: 1 Hour
measure: Feasibility: Polyp Detection Rate (PDR)
timeFrame: 1 Hour
Secondary outcomes:
measure: Usability
timeFrame: Day 1 (Day of Procedure)
Other outcomes:
measure: Intra-Procedural Pain (Exploratory Outcome)
timeFrame: Day 1 (Day of Procedure)
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong, Queen Mary Hospital
Study officials:
affiliation: Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital
name: Wai Keung Leung, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Colorectal Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital
name: Dominic Chi Chung Foo, Dr
role: PRINCIPAL_INVESTIGATOR
References: