Authorised Therapeutic use (Phase IV) colorectal cancer early detection

Efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy: a randomized parallel comparative trial. CLEAN+

EU CTIS ID: 2025-523748-11-00

What this study is testing

To compare the clinical efficacy of Clensia® versus Citrafleet®, measured by adenoma detection rate, in patients undergoing colorectal cancer screening colonoscopy.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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).
  • Hypermagnesemia.
  • Rhabdomyolysis.
  • Phenylketonuria.
  • Glucose-6-phosphate dehydrogenase deficiency.
  • Hypersensitivity to the active ingredients of excipients.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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).
  • Hypermagnesemia.
  • Rhabdomyolysis.
  • Phenylketonuria.
  • Glucose-6-phosphate dehydrogenase deficiency.
  • Hypersensitivity to the active ingredients of excipients.
  • Pregnancy or breastfeeding.
  • 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).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.