Colorectal ScreeningNCT05585879
Demonstrating Effective Salvage of Inadequate Colonoscopies
A study testing Pure-Vu EVS in people with Colorectal Screening, run by Motus GI Medical Technologies Ltd at 1 site in United States.
Trial summary
The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Screening
- What is being tested?
- Pure-Vu EVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 26 Apr 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible adults aged between 40-80
- Elective outpatient colonoscopy by participating gastroenterologist
Who cannot join
- Not competent to consent
- Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease
- History of colonic resection
- Prior incomplete colonoscopy due to patient anatomy
- Diverticulitis
- Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
Show all 9Show fewer
- Known or suspected colon stricture
- Hereditary Colorectal Cancer Syndrome
- Subject is pregnant or suspected pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Colonoscopy: Demonstrating Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System
The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs.
Read the detailed description
The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies when Pure-Vu EVS System is used to salvage inadequately prepped colons as defined by the multi-society guidelines (USMSTF).
- Conditions
- Colorectal Screening
- Being tested
- Pure-Vu EVS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure-Vu EVSDevice
Subjects will be enrolled until 115 inadequate bowel prep cases via SOC are accrued and subsequently treated with Pure-Vu EVS. Inadequate OCs defined as such if any of the following are met:
- Boston Bowel Preparation Score (BBPS) < 6 (Adequacy is defined as BBPS of 2 or greater in each segment)
- Inability to identify > 5mm polyps
| Study group | Role | What they receive |
|---|---|---|
| Pure-Vu EVS | Other | Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System.
Inadequate OCs defined as such if any of the following are met:
* BBPS < 6 (Adequacy is defined as BBPS of 2 or greater in each segment)
* Inability to identify > 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC.
The lower bound will be compared to a 35% performance goal. Receives: Device: Pure-Vu EVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incomplete colonoscopies
Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System.
Inadequate OCs defined as such if any of the following are met:
- BBPS < 6 (Adequacy is defined as BBPS of 2 or greater in each segment)
- Inability to identify > 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC.
The lower bound will be compared to a 35% performance goal.
Measured: Day 0 (Procedure Day)
Secondary outcomes (13)
Assessment of Screening
The following secondary endpoint will be assessed:
Number of polyps and adenomas: type, location, size, pathology and morphology
Measured: Day 0 (Procedure Day)
Assessment of Screening
Boston Bowel Prep Score (BBPS) before and after Pure-Vu EVS use. Throughout the procedure, the study endoscopist will be requested to document the pre-cleansing BBPS and post- cleansing BBPS for each colon segment.
Measured: Day 0 (Procedure Day)
Procedural Outcome
Sedation type The type of sedation will not be dictated by the study but will be documented.
Measured: Day 0 (Procedure Day)
Procedural Outcome
Cecum Intubation Rate
Measured: Day 0 (Procedure Day)
Assessment screening
Polyp Miss Rate (PMR)
Measured: Day 0 (Procedure Day)
Assessment screening
Adenoma Detection Rate (ADR)
Measured: Day 0 (Procedure Day)
Assessment screening
Adenoma Miss Rate (AMR)
Measured: Day 0 (Procedure Day)
Assessment screening
Adenoma Per Colonoscopy (APC)
Measured: Day 0 (Procedure Day)
Assessment screening
Adenomas Per Positive Patient (APP)
Measured: Day 0 (Procedure Day)
Assessment screening
Sessile Serrated Adenoma Detection Rate
Measured: Day 0 (Procedure Day)
Assessment Screening
Polyp Detection Rate (PDR)
Measured: Day 0 (Procedure Day)
Procedural Outcomes
Procedure Time: Time to cecum and withdrawal time
Measured: Day 0 (Procedure Day)
Procedural Outcomes
Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented.
Measured: Day 0 (Procedure Day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start3 Nov 2022
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Why it stopped: Strategy changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal ScreeningStudies 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
- Model description
- Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motus GI Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Pomeranz, Study director, Motus GI Medical Technologies Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585879
- Sponsor's protocol ID
- CL00052
- Status last verified
- May 2024
- First submitted
- 23 Sep 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Information regarding the study and study data will be made available via publication on clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Colonoscopy: Demonstrating Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System
- ClinicalTrials.gov ID
- NCT05585879
- Acronym / sponsor ID
- CL00052
- Conditions
- Colorectal Screening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategy changed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 19 Oct 2022 (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.
The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs.
Detailed description
The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies when Pure-Vu EVS System is used to salvage inadequately prepped colons as defined by the multi-society guidelines (USMSTF).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Pure-Vu EVS | Other | Device: Pure-Vu EVSRate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System. Inadequate OCs defined as such if any of the following are met: * BBPS < 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify > 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC. The lower bound will be compared to a 35% performance goal. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible adults aged between 40-80
- Elective outpatient colonoscopy by participating gastroenterologist
Key exclusion criteria (9 listed)
- Not competent to consent
- Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease
- History of colonic resection
- Prior incomplete colonoscopy due to patient anatomy
- Diverticulitis
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 |
|---|---|---|
| Pure-Vu EVSSubjects will be enrolled until 115 inadequate bowel prep cases via SOC are accrued and subsequently treated with Pure-Vu EVS. Inadequate OCs defined as such if any of the following are met: * Boston Bowel Preparation Score (BBPS) < 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify > 5mm polyps | Device | Pure-Vu EVS |
Primary outcome
Rate of incomplete colonoscopies
Time frame: Day 0 (Procedure Day)
Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System. Inadequate OCs defined as such if any of the following are met: * BBPS < 6 (Adequacy is defined as BBPS of 2 or greater in each segment) * Inability to identify > 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC. The lower bound will be compared to a 35% performance goal.
13 secondary outcomes
Assessment of Screening
Time frame: Day 0 (Procedure Day)
Assessment of Screening
Time frame: Day 0 (Procedure Day)
Procedural Outcome
Time frame: Day 0 (Procedure Day)
Procedural Outcome
Time frame: Day 0 (Procedure Day)
Assessment screening
Time frame: Day 0 (Procedure Day)
Assessment screening
Time frame: Day 0 (Procedure Day)
Assessment screening
Time frame: Day 0 (Procedure Day)
Assessment screening
Time frame: Day 0 (Procedure Day)
Assessment screening
Time frame: Day 0 (Procedure Day)
Assessment screening
Time frame: Day 0 (Procedure Day)
Assessment Screening
Time frame: Day 0 (Procedure Day)
Procedural Outcomes
Time frame: Day 0 (Procedure Day)
Procedural Outcomes
Time frame: Day 0 (Procedure Day)
Results and safety
The study was stopped early (reason given: Strategy changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- More information about Pure-VU® EVSLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information regarding the study and study data will be made available via publication on clinicaltrials.gov.
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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.
Mark Pomeranz study director
Motus GI Medical Technologies Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure-Vu EVS in people with Colorectal Screening, run by Motus GI Medical Technologies Ltd at 1 site 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 2 inclusion and 9 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 13 May 2024. 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 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.
Are results available for this study?
The study was stopped early (reason given: Strategy changed). 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?
Rate of incomplete colonoscopies (time frame: Day 0 (Procedure Day)). 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 13 May 2024.