Colorectal CancerNCT04700410
Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation
A study testing Pure-Vu System in people with Colorectal Cancer and Colonic Adenoma, run by Radboud University Medical Center at 2 sites in 2 countries.
Trial summary
The diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Colonic Adenoma, Bowel Preparation
- 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
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2021to 1 May 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, aged between 18 and 80 years, referred and scheduled for either screening, diagnostic, or surveillance colonoscopy.
- Poor bowel preparation within the last 2 years, defined as a BBPS <6 or need for repeat colonoscopy or shortening of surveillance interval due to poor bowel preparation
Who cannot join
- Prior colon resection
- Previous colorectal cancer
- Colitis
- Lower gastrointestinal bleeding with hemodynamic instability
- Bowel obstruction
- Pregnancy or lactating
Show all 9Show fewer
- ASA > 3
- Insufficiently corrected anticoagulation disorders
- Inability to provide informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525GA
About this study
Official title: A New Method for Bowel Cleansing in Patients With a History of Poor Bowel Preparation - A Multicenter Feasibility Study With the Pure-Vu System
The diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. This study aims to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation, in a single arm international multicenter feasibility study.
Read the detailed description
Rationale: It is widely acknowledged that the efficacy and safety of colonoscopy depends on the quality of the pre-procedural bowel preparation. Despite its importance, the proportion of colonoscopies with inadequate bowel preparation still ranges from 6.8-33% across studies. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. (1, 2) Evidence to recommend a specific bowel cleansing regimen in these patients is currently lacking. (3) Mostly, patients with previous bowel preparation are advised to drink more oral purgatives, which is very difficult and unpleasant for patients and therefore often fails.
The aim of this study is to evaluate if an intra-procedural bowel cleaning device, the Pure-VuTM System (Tirat Carmel, Israel) can be used to achieve an adequate level of bowel cleansing in patients with previous poor bowel preparation.
Objective: The aim of this study is to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation (Boston Bowel Preparation Scale [BBPS]<6).
Study design: We will perform a single arm international multicenter colonoscopy trial. Adult patients with previous poor bowel preparation (BBPS<6) will be invited to participate in our study (n= 44). All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System. The BBPS will be assessed before and after segmental washing by the endoscopist who performs the procedure and later by an independent endoscopist (photos).
Study population: Adult patients with poor bowel preparation within the last 2 years. Exclusion criteria; previous colon resection, previous colorectal cancer, colitis, lower gastrointestinal bleeding with hemodynamic instability, ASA>3, insufficiently corrected anticoagulation disorders, inability to provide informed consent.
Primary endpoint: The primary endpoint of the study will be the BBPS-score before and after intra-procedural bowel cleaning with the Pure-Vu System.
Secondary endpoints include:
- Total number of colon lesions specified by histology
- Adenoma detection rate
- Cecal intubation rates
- Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)
- Total amount of water used for washing and total amount of fluids+residual stool removed.
- Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale)
- System usability
- Endoscopists' learning curve
- Safety outcomes
Nature and extent of the burden and risk associated with participation, benefit and group relatedness: Colonoscopy is a commonly performed procedure and the overall serious adverse event (SAE) rate is low, around 2.8 per 1000 colonoscopies. The risk of adverse events (AE) with the Pure-Vu are believed to be equivalent to conventional colonoscopy, including bleeding and perforation risks (13). Participation in this study could potentially benefit colonoscopy patients because the Pure-Vu is expected to improve the quality of colonoscopy. Inadequate bowel cleansing may be prevented by the Pure-Vu System. Inadequate bowel cleansing is associated with lower adenoma detection rates (ADR), lower completion rates, longer procedure times, more complications and a higher need for repeat procedures.(4, 5) In addition, Pure-Vu reduces the reliance on patients pre-procedural bowel preparation which is often considered the most deterrent part of colonoscopy by patients.
- Conditions
- Colorectal Cancer, Colonic Adenoma, Bowel Preparation
- Being tested
- Pure-Vu System
- Keywords
- Bowel preparation, colonoscopy, colorectal cancer, adenoma detection rate, endoscopy, therapeutic irrigation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure-Vu SystemDevice
All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System.
| Study group | Role | What they receive |
|---|---|---|
| Pure-Vu | Experimental | All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System (single arm) Receives: Device: Pure-Vu System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system.
Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows:
- Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared.
- Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid.
- Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well.
- Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.
Measured: 1 day (day of intervention)
Boston Bowel Preparation scale (BBPS)-score after cleaning with the Pure-Vu system.
Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows:
- Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared.
- Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid.
- Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well.
- Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.
Measured: 1 day (day of intervention)
Secondary outcomes (9)
Total number of colon lesions specified by histology
Measured: 1 day (day of intervention)
Adenoma detection rate
Measured: 1 day (day of intervention)
Cecal intubation rates
Measured: 1 day (day of intervention)
Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)
Measured: 1 day (day of intervention)
Total amount of water used for washing and total amount of fluids+residual stool removed.
Measured: 1 day (day of intervention)
Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale)
A visual analogue scale from 0 to 10, in which higher numbers indicate a higher level of discomfort.
Measured: 1 month
System usability
general ease of use, ease of rectum insertion, ease of angulation, ease of advancement, device stiffness, ease of polyp resection holding forces, ease of retroflexion,
- Unacceptable
- Difficult
- Acceptable
- Good (as good as conventional colonoscopy)
- Excellent
Measured: through study completion, an average of 1 year
Endoscopists' learning curve
Measured: through study completion, an average of 1 year
Number of adverse events after study intervention
Safety outcomes (adverse events): Severe adverse events will be subcategorized cardiac (cardiac ischemia, heart failure, arrhythmia, other) pulmonary (exacerbation of Chronic Obstructive Pulmonary Disease, infectious, other), neurological (stroke, cerebrovascular accident, bleeding, other), and other (surgical interventions etc.).
Measured: 48 hours and 1month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jun 2021
- Primary completion28 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- single arm international multicenter colonoscopy trial
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Mainz, Motus GI Medical Technologies Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700410
- Sponsor's protocol ID
- NL66613.091.18
- Status last verified
- Aug 2022
- First submitted
- 17 Dec 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Bowel Cleansing in Patients With a History of Poor Bowel Preparation - A Multicenter Feasibility Study With the Pure-Vu System
- ClinicalTrials.gov ID
- NCT04700410
- Acronym / sponsor ID
- NL66613.091.18
- Conditions
- Colorectal Cancer, Colonic Adenoma, Bowel Preparation
- Keywords
- Bowel preparation, colonoscopy, colorectal cancer, adenoma detection rate, endoscopy, therapeutic irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- University Medical Center Mainz, Motus GI Medical Technologies Ltd
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Jan 2021 (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 diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. This study aims to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation, in a single arm international multicenter feasibility study.
Detailed description
Rationale: It is widely acknowledged that the efficacy and safety of colonoscopy depends on the quality of the pre-procedural bowel preparation. Despite its importance, the proportion of colonoscopies with inadequate bowel preparation still ranges from 6.8-33% across studies. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. (1, 2) Evidence to recommend a specific bowel cleansing regimen in these patients is currently lacking. (3) Mostly, patients with previous bowel preparation are advised to drink more oral purgatives, which is very difficult and unpleasant for patients and therefore often fails.
The aim of this study is to evaluate if an intra-procedural bowel cleaning device, the Pure-VuTM System (Tirat Carmel, Israel) can be used to achieve an adequate level of bowel cleansing in patients with previous poor bowel preparation.
Objective: The aim of this study is to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation (Boston Bowel Preparation Scale [BBPS]<6).
Study design: We will perform a single arm international multicenter colonoscopy trial. Adult patients with previous poor bowel preparation (BBPS<6) will be invited to participate in our study (n= 44). All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System. The BBPS will be assessed before and after segmental washing by the endoscopist who performs the procedure and later by an independent endoscopist (photos).
Study population: Adult patients with poor bowel preparation within the last 2 years. Exclusion criteria; previous colon resection, previous colorectal cancer, colitis, lower gastrointestinal bleeding with hemodynamic instability, ASA>3, insufficiently corrected anticoagulation disorders, inability to provide informed consent.
Primary endpoint: The primary endpoint of the study will be the BBPS-score before and after intra-procedural bowel cleaning with the Pure-Vu System.
Secondary endpoints include:
- Total number of colon lesions specified by histology
- Adenoma detection rate
- Cecal intubation rates
- Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)
- Total amount of water used for washing and total amount of fluids+residual stool removed.
- Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale)
- System usability
- Endoscopists' learning curve
- Safety outcomes
Nature and extent of the burden and risk associated with participation, benefit and group relatedness: Colonoscopy is a commonly performed procedure and the overall serious adverse event (SAE) rate is low, around 2.8 per 1000 colonoscopies. The risk of adverse events (AE) with the Pure-Vu are believed to be equivalent to conventional colonoscopy, including bleeding and perforation risks (13). Participation in this study could potentially benefit colonoscopy patients because the Pure-Vu is expected to improve the quality of colonoscopy. Inadequate bowel cleansing may be prevented by the Pure-Vu System. Inadequate bowel cleansing is associated with lower adenoma detection rates (ADR), lower completion rates, longer procedure times, more complications and a higher need for repeat procedures.(4, 5) In addition, Pure-Vu reduces the reliance on patients pre-procedural bowel preparation which is often considered the most deterrent part of colonoscopy by patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm international multicenter colonoscopy trial
| Arm | Type | Receives |
|---|---|---|
| Pure-Vu | Experimental | Device: Pure-Vu SystemAll patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System (single arm) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients, aged between 18 and 80 years, referred and scheduled for either screening, diagnostic, or surveillance colonoscopy.
- Poor bowel preparation within the last 2 years, defined as a BBPS <6 or need for repeat colonoscopy or shortening of surveillance interval due to poor bowel preparation
Key exclusion criteria (9 listed)
- Prior colon resection
- Previous colorectal cancer
- Colitis
- Lower gastrointestinal bleeding with hemodynamic instability
- Bowel obstruction
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 SystemAll patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System. | Device | Pure-Vu |
Primary outcome
Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system.
Time frame: 1 day (day of intervention)
Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows: 0) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared. 1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. 2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well. 3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.
Boston Bowel Preparation scale (BBPS)-score after cleaning with the Pure-Vu system.
Time frame: 1 day (day of intervention)
Boston Bowel Preparation scale (BBPS): The adequacy of bowel preparation should be assessed after all appropriate efforts to clear residual debris is completed. All three bowel regions of the colon will be scored (i.e., the right colon, transverse colon, and left colon) from 0-3 points by the endoscopist. The segment scores are summed for a total BBPS ranging from 0 to 9. The points will be assigned as follows: 0) Unprepared colon segment with mucosa not seen because of solid stool that could not be cleared. 1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. 2. Minor amount of residual staining, small fragments of stool, and/or opaque liquid but mucosa of colon segment seen well. 3. Entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. Each segment of the colon received a segmental score from 0- 3.
9 secondary outcomes
Total number of colon lesions specified by histology
Time frame: 1 day (day of intervention)
Adenoma detection rate
Time frame: 1 day (day of intervention)
Cecal intubation rates
Time frame: 1 day (day of intervention)
Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions)
Time frame: 1 day (day of intervention)
Total amount of water used for washing and total amount of fluids+residual stool removed.
Time frame: 1 day (day of intervention)
Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale)
Time frame: 1 month
System usability
Time frame: through study completion, an average of 1 year
Endoscopists' learning curve
Time frame: through study completion, an average of 1 year
Number of adverse events after study intervention
Time frame: 48 hours and 1month after intervention
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 21 Nov 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request
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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.
2 sites in 2 countries: 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 Colorectal Cancer and Colonic Adenoma, run by Radboud University Medical Center at 2 sites in 2 countries.
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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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?
Boston Bowel Preparation scale (BBPS)-score before cleaning with the Pure-Vu system. (time frame: 1 day (day of intervention)). The study lists 2 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 21 Nov 2024.