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JOURNAL ONKOLOGIE – STUDIE

Bowel Cleansing Performance of the Pure-Vu System in Patients With a History of Poor Bowel Preparation

Noch nicht rekrutierend

NCT-Nummer:
NCT04700410

Studienbeginn:
Mai 2021

Letztes Update:
17.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Colorectal Neoplasms, Adenoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Radboud University

Collaborator:
University Medical Center Mainz, Motus GI Medical Technologies Ltd,

Studienlocations
(2 von 2)

University Medical Center Mainz
Mainz
(Rheinland-Pfalz)
Germany» Google-Maps
Ansprechpartner:
Helmut Neumann, professor
Phone: 6131 17 6836
Phone (ext.): +49
E-Mail: tanja.bender@unimedizin-mainz.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- Prior colon resection

- Previous colorectal cancer

- Colitis

- Lower gastrointestinal bleeding with hemodynamic instability

- Bowel obstruction

- Pregnancy or lactating

- ASA > 3

- Insufficiently corrected anticoagulation disorders

- Inability to provide informed consent

Studien-Rationale

Primary outcome:

1. 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. 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.

2. 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. 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.

Secondary outcome:

1. Total number of colon lesions specified by histology (Time Frame - 1 day (day of intervention))

2. Adenoma detection rate (Time Frame - 1 day (day of intervention))

3. Cecal intubation rates (Time Frame - 1 day (day of intervention))

4. Procedure times (total procedure time, cecal intubation time, withdrawal time, time for all other interventions) (Time Frame - 1 day (day of intervention))

5. Total amount of water used for washing and total amount of fluids+residual stool removed. (Time Frame - 1 day (day of intervention))

6. Patient reported outcomes (level of discomfort during bowel preparation and during colonoscopy on a visual analog scale) (Time Frame - 1 month):
A visual analogue scale from 0 to 10, in which higher numbers indicate a higher level of discomfort.

7. System usability (Time Frame - through study completion, an average of 1 year):
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

8. Endoscopists' learning curve (Time Frame - through study completion, an average of 1 year)

9. Number of adverse events after study intervention (Time Frame - 48 hours and 1month after 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.).

Geprüfte Regime

  • Pure-Vu System:
    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.

Quelle: ClinicalTrials.gov


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