Colonic PolypNCT03979690
Feasibility Study of a Novel Single Use Robotic Colonoscopy System
A study testing NISInspire-C System in people with Colonic Polyp and Colon Adenoma, run by Bio-Medical Engineering (HK) Limited at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colon Adenoma, Colorectal Cancer
- What is being tested?
- NISInspire-C System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Jun 2019to 16 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- NISInspire-C System
- Keywords
- Robotic Colonoscopy, Tandem Colonoscopy, NISInspire-C System, Single Use Colonoscope, Colonoscopy
- Medical subject headings
- Colonic Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NISInspire-C SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Subjects Receiving Colonoscopy | Experimental | Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy Receives: Device: NISInspire-C System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of Intra-Operative and Post-Operative Adverse Events
Number of Adverse Events
Measured: 10 Days
Feasibility: Caecal Intubation Rate (CIR)
CIR: Number of Times Caecum is Reached
Measured: 1 Hour
Feasibility: Time-to-Caecum (TTC)
TTC: Time to Reach Caecum
Measured: 1 Hour
Feasibility: Polyp Detection Rate (PDR)
PDR: Number of Polyps Detected
Measured: 1 Hour
Secondary outcomes (1)
Usability
Feedback on General Usage of the NISInspire-C Disposable Colonoscope
Measured: Day 1 (Day of Procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start12 Jun 2019
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Medical Engineering (HK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Wai Keung Leung, Professor, Principal investigator, Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong, Queen Mary HospitalDominic Chi Chung Foo, Dr, Principal investigator, Division of Colorectal Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979690
- Sponsor's protocol ID
- NISInspire-001
- Other IDs
- HKUCTR-2616, HKUCTR-2617
- Status last verified
- Oct 2019
- First submitted
- 3 Jun 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03979690
- Acronym / sponsor ID
- NISInspire-001
- Conditions
- Colonic Polyp, Colon Adenoma, Colorectal Cancer
- Keywords
- Robotic Colonoscopy, Tandem Colonoscopy, NISInspire-C System, Single Use Colonoscope, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bio-Medical Engineering (HK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- The University of Hong Kong
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Receiving Colonoscopy | Experimental | Device: NISInspire-C SystemSubjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NISInspire-C SystemThe 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. | Device | Subjects Receiving Colonoscopy |
Primary outcome
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
1 secondary outcome
Usability
Time frame: Day 1 (Day of Procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Keung Leung, Professor principal investigator
Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Dominic Chi Chung Foo, Dr principal investigator
Division of Colorectal Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NISInspire-C System in people with Colonic Polyp and Colon Adenoma, run by Bio-Medical Engineering (HK) Limited at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of Intra-Operative and Post-Operative Adverse Events (time frame: 10 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.