Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy (CLEAN+)
6 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
818
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Maria Pellisé
- Numer telefonu: +34 932275400
- E-mail: MPELLISE@clinic.cat
Kopia zapasowa kontaktu do badania
- Nazwa: Judit Pich
- Numer telefonu: 2815 +34 932275400
- E-mail: JPICH@recerca.clinic.cat
Lokalizacje studiów
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Barcelona
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Barcelona, Barcelona, Hiszpania, 08036
- Rekrutacyjny
- Hospital Clinic de Barcelona
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Główny śledczy:
- Maria Pellisé
-
Kontakt:
- Maria Pellisé
- E-mail: MPELLISE@clinic.cat
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Adenoma detection rate
Ramy czasowe: 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)).
|
week 2 (Colonoscopy visit)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Lesion detection rate
Ramy czasowe: 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.
|
week 2 (Colonoscopy visit)
|
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Adenomas per colonoscopy
Ramy czasowe: week 2 (Colonoscopy visit)
|
Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
|
week 2 (Colonoscopy visit)
|
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Presence of foam
Ramy czasowe: 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
Ramy czasowe: week 2 (Colonoscopy visit)
|
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
Ramy czasowe: week 2 (Colonoscopy visit)
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: week 2 (Colonoscopy visit)
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: week 2 (Colonoscopy visit)
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
18 maja 2026
Zakończenie podstawowe (Szacowany)
1 maja 2028
Ukończenie studiów (Szacowany)
1 maja 2028
Daty rejestracji na studia
Pierwszy przesłany
26 września 2025
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 lipca 2026
Pierwszy wysłany (Rzeczywisty)
10 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
10 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2025-523748-11-00
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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