Gastrointestinal DiseasesNCT02651857
Exploratory Study of Upper and Lower Endoscopic Fuse System
A study testing Fuse® Colonoscope and Fuse® Gastroscope in people with Gastrointestinal Diseases, run by EndoChoice Inc..
Trial summary
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Fuse® Colonoscope and Fuse® Gastroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 27 Apr 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female patients ages of 18-75
- The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
- Signed informed consent form
Who cannot join
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
- Patients who are unable to consent
- Pregnant female patients of any age.
About this study
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
Read the detailed description
The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Fuse® Colonoscope, Fuse® Gastroscope
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuse® ColonoscopeDevice
Endoscopic diagnostic procedures for lower GI tract
Fuse® GastroscopeDevice
Endoscopic diagnostic procedures for upper GI tract
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy exploratory single arm | Experimental | Not described Receives: Device: Fuse® Colonoscope; Device: Fuse® Gastroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance, usability and ease of use (performance questionnaire)
The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer
Measured: Through study completion, estimate average of 1 year
Secondary outcomes (1)
Safety (adverse and severe adverse events)
Establish safety of the device by measure of adverse and severe adverse events, if such occur.
Measured: Through study completion, estimate average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startNov 2015
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EndoChoice Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651857
- Sponsor's protocol ID
- Exploratory study
- Status last verified
- Jan 2016
- First submitted
- 5 Jan 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Upper and Lower Endoscopic Fuse System
- ClinicalTrials.gov ID
- NCT02651857
- Acronym / sponsor ID
- Exploratory study
- Conditions
- Gastrointestinal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- EndoChoice Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017
- First posted
- 11 Jan 2016 (estimated)
- 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.
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
Detailed description
The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy exploratory single arm | Experimental | Device: Fuse® Colonoscope, Device: Fuse® Gastroscope |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and Female patients ages of 18-75
- The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
- Signed informed consent form
Key exclusion criteria (3 listed)
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
- Patients who are unable to consent
- Pregnant female patients of any age.
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 |
|---|---|---|
| Fuse® ColonoscopeEndoscopic diagnostic procedures for lower GI tract | Device | Endoscopy exploratory single arm |
| Fuse® GastroscopeEndoscopic diagnostic procedures for upper GI tract | Device | Endoscopy exploratory single arm |
Primary outcome
Performance, usability and ease of use (performance questionnaire)
Time frame: Through study completion, estimate average of 1 year
The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer
1 secondary outcome
Safety (adverse and severe adverse events)
Time frame: Through study completion, estimate average of 1 year
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 28 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fuse® Colonoscope and Fuse® Gastroscope in people with Gastrointestinal Diseases, run by EndoChoice Inc..
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 3 inclusion and 3 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Performance, usability and ease of use (performance questionnaire) (time frame: Through study completion, estimate average of 1 year). 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 28 Apr 2017.