Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy (CLEAN+)
6 juli 2026 bijgewerkt door: Fundacion Clinic per a la Recerca Biomédica
Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy: a Randomized Parallel Comparative Trial CLEAN+
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
818
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Maria Pellisé
- Telefoonnummer: +34 932275400
- E-mail: MPELLISE@clinic.cat
Studie Contact Back-up
- Naam: Judit Pich
- Telefoonnummer: 2815 +34 932275400
- E-mail: JPICH@recerca.clinic.cat
Studie Locaties
-
-
Barcelona
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Barcelona, Barcelona, Spanje, 08036
- Werving
- Hospital Clinic de Barcelona
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Hoofdonderzoeker:
- Maria Pellisé
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Contact:
- Maria Pellisé
- E-mail: MPELLISE@clinic.cat
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Men and women aged 50 to 69.
- Have participated in the early detection program for colorectal cancer.
- Positive result in the fecal occult blood test (≥20 μg Hb/g feces).
- Scheduled screening colonoscopy at Hospital Clínic de Barcelona.
- Signed informed consent form.
Exclusion Criteria:
- Severe renal failure (grade IV or V) (Annex 6, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 7, NYHA Scale).
- Colonoscopy within the last year.
- Barthel Index of <20 (Annex 5, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 8, Rome IV Criteria).
- Mental disability or severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders, and bipolar disorders).
- Do not understand spoken or written Catalan or Spanish.
- Partial or total colon resection.
- Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
- Terminal illness or serious illness/disability that contraindicates subsequent colon study.
- Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon).
- Hypermagnesemia.
- Rhabdomyolysis.
- Phenylketonuria.
- Glucose-6-phosphate dehydrogenase deficiency.
- Hypersensitivity to the active ingredients of excipients.
- Pregnancy or breastfeeding.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Clensia®
Clensia®, powder for oral solution in sachet.
To be taken in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.
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Participants will take the treatment in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.
|
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Experimenteel: Citrafleet®
Citrafleet®, powder for oral solution in sachet.
To be taken in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.
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Participants will take the treatment in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adenoma detection rate
Tijdsspanne: week 2 (Colonoscopy visit)
|
Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)).
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week 2 (Colonoscopy visit)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Lesion detection rate
Tijdsspanne: week 2 (Colonoscopy visit)
|
Lesion detection rate, defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group.
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week 2 (Colonoscopy visit)
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Adenomas per colonoscopy
Tijdsspanne: week 2 (Colonoscopy visit)
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Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
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week 2 (Colonoscopy visit)
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Presence of foam
Tijdsspanne: week 2 (Colonoscopy visit)
|
The presence of foam using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).
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week 2 (Colonoscopy visit)
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Presence of bubbles
Tijdsspanne: week 2 (Colonoscopy visit)
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The presence of bubbles using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).
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week 2 (Colonoscopy visit)
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Quality of colon cleansing
Tijdsspanne: week 2 (Colonoscopy visit)
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The quality of colon cleansing using the Boston Scale, in which each colonic segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent).
A total score greater than or equal to 6 and greater than or equal to 2 in each segment will be considered adequate.
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week 2 (Colonoscopy visit)
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Need for washing tools during colonoscopy
Tijdsspanne: week 2 (Colonoscopy visit)
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Need for washing tools during colonoscopy.
The amount of wash water used during the colonoscopy to complete the test satisfactorily is counted.
Likewise, the volume of simethicone used will be counted if it is considered necessary.
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week 2 (Colonoscopy visit)
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Cecal intubation rate
Tijdsspanne: week 2 (Colonoscopy visit)
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Cecal intubation rate.
The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.
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week 2 (Colonoscopy visit)
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Cecal intubation time
Tijdsspanne: week 2 (Colonoscopy visit)
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Cecal intubation time.
Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.
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week 2 (Colonoscopy visit)
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Endoscope removal time
Tijdsspanne: week 2 (Colonoscopy visit)
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Endoscope removal time.
Defined as the time elapsed between reaching the cecal fundus and completion of the endoscopy, including the time spent cleaning the colon and excluding endoscopic treatment of lesions.
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week 2 (Colonoscopy visit)
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Requires repeat colonoscopy due to poor preparation
Tijdsspanne: week 2 (Colonoscopy visit)
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Proportion of patients who, after undergoing colonoscopy, require repeat colonoscopy due to poor preparation, defined as a total score of less than 6 or less than 2 in one of the three segments according to the Boston Scale
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week 2 (Colonoscopy visit)
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Adherence to the intake of the preparation
Tijdsspanne: week 2 (Colonoscopy visit)
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Adherence to the intake of the preparation assessed by compliance with the intake in three degrees: completely, more than 50%, less than 50% or not at all (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Ease of taking the preparation
Tijdsspanne: week 2 (Colonoscopy visit)
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Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Palatability of the preparation
Tijdsspanne: week 2 (Colonoscopy visit)
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Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Willingness to repeat the intake of the preparation
Tijdsspanne: week 2 (Colonoscopy visit)
|
Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Overall satisfaction with the intake of the preparation
Tijdsspanne: week 2 (Colonoscopy visit)
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Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Endoscopist's satisfaction with the cleaning of faecal remains and bubbles
Tijdsspanne: week 2 (Colonoscopy visit)
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Endoscopist's satisfaction with the cleaning of faecal remains and bubbles, assessed with a numerical assessment scale from 0 = very dissatisfied to 10 = very satisfied (Data collection form).
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week 2 (Colonoscopy visit)
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Rate of adverse events
Tijdsspanne: week 2 (Colonoscopy visit) and week 4 (visit 2)
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Rate of adverse events including symptoms such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness and dry mouth, which will be assessed in the Tolerability and Satisfaction Questionnaire (Tolerability and Satisfaction Questionnaire).
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week 2 (Colonoscopy visit) and week 4 (visit 2)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
18 mei 2026
Primaire voltooiing (Geschat)
1 mei 2028
Studie voltooiing (Geschat)
1 mei 2028
Studieregistratiedata
Eerst ingediend
26 september 2025
Eerst ingediend dat voldeed aan de QC-criteria
6 juli 2026
Eerst geplaatst (Werkelijk)
10 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
6 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2025-523748-11-00
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .