Gentle ColonoscopyPhase 4SC20 ScopeNCT02279836
Single Arm Post-marketing Study of SC20 Colonoscope
A Phase 4 study testing SC20 Colonoscope in people with Gentle Colonoscopy, run by Invendo Medical GmbH at 3 sites in United States.
Trial summary
The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gentle Colonoscopy
- What is being tested?
- SC20 Colonoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any indication for colonoscopy
- Willing to give informed consent
- Willing to consume 2-4 liters of bowel prep
Who cannot join
- An age younger than 18 years
- Congestive heart failure
- Renal insufficiency
- Intestinal obstruction
- Any acute life-threatening condition (in the opinion of the investigator)
- Current pregnancy
Show all 10Show fewer
- Abdominal surgery in the past 6 months
- Bleeding disorders
- Inability to provide informed consent
- Any other contraindication to colonoscopy (e.g. fulminant colitis or acute diverticulitis)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bellevue Hospital Center
New York, New York, 10016
NYU Langone Medical Center Ambulatory care
New York, New York, 10016
New York Presbyterian Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Open Label, Multi-center, Single Arm Post-marketing Study of SC20 Colonoscope and Colonoscopy System for Colonoscopy in Male and Female Patients >18 Years Old
The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population.
Read the detailed description
The objective of the study is to expand data collection and product exposure in a controlled clinical setting and gather data regarding the performance of the Invendo SC20 colonoscope in a real-world US population. The objective of the study is to specifically monitor three points:
- The diagnostic performance of the device including polyp and adenoma detection rates;
- The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions);
- Performance of the device in a typical colonoscopy population, including patients with underlying inflammatory bowel disease (IBD), previous pelvic surgery or irradiation, obesity, diverticular disease, and previous colorectal surgery, as they present in the study population (see below C.).
- Conditions
- Gentle Colonoscopy
- Being tested
- SC20 Colonoscope
- Keywords
- Patients with any indication for colonoscopy in the U.S.A.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC20 ColonoscopeDevice
Single Arm Post-Marketing Study of SC20 Colonoscope
| Study group | Role | What they receive |
|---|---|---|
| Single arm post-marketing Study | Other | SC20 Colonoscope and Colonoscopy System For Colonoscopy Receives: Device: SC20 Colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure)
Measured: average 6 to 12 months
Secondary outcomes (1)
2. Detection of polyps, adenomas and other lesions in all individuals
Measured: average 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Study was stopped due to the expected introduction of a next product generation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gentle ColonoscopyStudies 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 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invendo Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Goodman, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279836
- Sponsor's protocol ID
- Invendo s14-01040
- Acronym
- SC20 Scope
- Status last verified
- Feb 2015
- First submitted
- 28 Oct 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-center, Single Arm Post-marketing Study of SC20 Colonoscope and Colonoscopy System for Colonoscopy in Male and Female Patients >18 Years Old
- ClinicalTrials.gov ID
- NCT02279836
- Acronym / sponsor ID
- SC20 Scope / Invendo s14-01040
- Conditions
- Gentle Colonoscopy
- Keywords
- Patients with any indication for colonoscopy in the U.S.A.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to the expected introduction of a next product generation.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Invendo Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 31 Oct 2014 (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.
The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population.
Detailed description
The objective of the study is to expand data collection and product exposure in a controlled clinical setting and gather data regarding the performance of the Invendo SC20 colonoscope in a real-world US population. The objective of the study is to specifically monitor three points:
- The diagnostic performance of the device including polyp and adenoma detection rates;
- The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions);
- Performance of the device in a typical colonoscopy population, including patients with underlying inflammatory bowel disease (IBD), previous pelvic surgery or irradiation, obesity, diverticular disease, and previous colorectal surgery, as they present in the study population (see below C.).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm post-marketing Study | Other | Device: SC20 ColonoscopeSC20 Colonoscope and Colonoscopy System For Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any indication for colonoscopy
- Willing to give informed consent
- Willing to consume 2-4 liters of bowel prep
Key exclusion criteria (10 listed)
- An age younger than 18 years
- Congestive heart failure
- Renal insufficiency
- Intestinal obstruction
- Any acute life-threatening condition (in the opinion of the investigator)
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 |
|---|---|---|
| SC20 ColonoscopeSingle Arm Post-Marketing Study of SC20 Colonoscope | Device | Single arm post-marketing Study |
Primary outcome
1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure)
Time frame: average 6 to 12 months
1 secondary outcome
2. Detection of polyps, adenomas and other lesions in all individuals
Time frame: average 6 to 12 months
Results and safety
The study was stopped early (reason given: Study was stopped due to the expected introduction of a next product generation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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.
Adam Goodman, MD principal investigator
NYU Langone Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SC20 Colonoscope in people with Gentle Colonoscopy, run by Invendo Medical GmbH at 3 sites in United States.
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 10 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: stopped early, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to the expected introduction of a next product generation.). Results are not available in the source record.
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?
1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure) (time frame: average 6 to 12 months). 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 4 Feb 2015.