Gastrointestinal DiseaseRESCueNCT04285008
Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation
A study testing Pure-Vu System in people with Gastrointestinal Disease and Colorectal Cancer, run by Motus GI Medical Technologies Ltd at 1 site in United States.
Trial summary
The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disease, Colorectal Cancer
- What is being tested?
- Pure-Vu System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 15 Apr 2021
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults > age 22
- Elective outpatient colonoscopy by participating gastroenterologist
- Stool clarity grade 1-3 at presentation for colonoscopy
Who cannot join
- Not competent to consent
- Bleeding disorder - known or suspected
- Hereditary Gastrointestinal Cancer syndrome
- Known PT INR > 1.5
- Know elevated PTT
- Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy
Show all 19Show fewer
- Known platelet count < 50,000
- Known absolute neutrophil count < 1,000
- History of surgical colon resection
- Pre-colonoscopy intent to enter terminal ileum
- Prior incomplete colonoscopy due to technical \& non-bowel preparation related reasons
- Regular use of non-topical steroid
- Pregnant
- Prisoner or institutionalized for any reason
- Psychiatric illness greater than mild
- Colonoscopy without anesthesia administered (MAC) sedation
- Diverticulitis
- Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
- Known or suspected colon stricture
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.
Read the detailed description
Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System.
Subjects will be enrolled at up to 4 clinical sites in the United States.
primary endpoint- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)
The following secondary endpoints will be determined:
- Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy
- Colonoscopy procedural measures for Intervention and Control arms
- Endoscopists' experience
- Safety assessment for all subjects on the day of procedure per endoscopist
- Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy
- Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy
Follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the Pure-Vu System in the future.
- Conditions
- Gastrointestinal Disease, Colorectal Cancer
- Being tested
- Pure-Vu System
- Keywords
- colonoscopy
- Medical subject headings
- Gastrointestinal Diseases, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure-Vu SystemDevice
The Pure-Vu System is Food and Drug Administration (FDA) approved device (K191220), intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
| Study group | Role | What they receive |
|---|---|---|
| standard Colonoscopy | No intervention | Control arm Colonoscopy procedure using standard flushing and suctioning - standard of care |
| Pure-Vu System | Other | Intervention - Colonoscopy procedure using Pure-Vu System Receives: Device: Pure-Vu System |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure
A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start3 Mar 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Why it stopped: Sponsor has terminated study due to COVID-19 related concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to Intervention or Control arm will use stratification by site, endoscopist and blocking. Sites are expected to contribute approximately equal numbers of procedures, and no site will be allowed to contribute more than 50% of the target sample size. The randomization sequences will be provided in advance by the study's statistician using an online system to obtain the randomization assignment and the corresponding colonoscope will be prepared. Randomization assignment will be recorded for each subject.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motus GI Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285008
- Sponsor's protocol ID
- CL00048
- Acronym
- RESCue
- Status last verified
- Jun 2020
- First submitted
- 24 Feb 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation
- ClinicalTrials.gov ID
- NCT04285008
- Acronym / sponsor ID
- RESCue / CL00048
- Conditions
- Gastrointestinal Disease, Colorectal Cancer
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor has terminated study due to COVID-19 related concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Motus GI Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 26 Feb 2020 (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 primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.
Detailed description
Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System.
Subjects will be enrolled at up to 4 clinical sites in the United States.
primary endpoint- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)
The following secondary endpoints will be determined:
- Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy
- Colonoscopy procedural measures for Intervention and Control arms
- Endoscopists' experience
- Safety assessment for all subjects on the day of procedure per endoscopist
- Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy
- Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy
Follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the Pure-Vu System in the future.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization to Intervention or Control arm will use stratification by site, endoscopist and blocking. Sites are expected to contribute approximately equal numbers of procedures, and no site will be allowed to contribute more than 50% of the target sample size. The randomization sequences will be provided in advance by the study's statistician using an online system to obtain the randomization assignment and the corresponding colonoscope will be prepared. Randomization assignment will be recorded for each subject.
| Arm | Type | Receives |
|---|---|---|
| standard Colonoscopy | No intervention | –Control arm Colonoscopy procedure using standard flushing and suctioning - standard of care |
| Pure-Vu System | Other | Device: Pure-Vu SystemIntervention - Colonoscopy procedure using Pure-Vu System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults > age 22
- Elective outpatient colonoscopy by participating gastroenterologist
- Stool clarity grade 1-3 at presentation for colonoscopy
Key exclusion criteria (19 listed)
- Not competent to consent
- Bleeding disorder - known or suspected
- Hereditary Gastrointestinal Cancer syndrome
- Known PT INR > 1.5
- Know elevated PTT
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 SystemThe Pure-Vu System is Food and Drug Administration (FDA) approved device (K191220), intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood. | Device | Pure-Vu System |
Primary outcome
rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure
Time frame: Up to 2 hours
A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No
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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.
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 System in people with Gastrointestinal Disease and Colorectal Cancer, 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 3 inclusion and 19 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: withdrawn, as of the sponsor's last update on 25 Jun 2020. 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 withdrawn before enrolling participants, so there are no results.
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 adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure (time frame: Up to 2 hours). 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 25 Jun 2020.