Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07465705

Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)

Led by NTC srl · Updated on 2026-03-13

412

Participants Needed

18

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.

CONDITIONS

Official Title

Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to consent and provide signed informed consent
  • Age 18 years or older
  • Scheduled for elective colonoscopy following ESGE guidelines
  • Willing and able to complete the study and follow instructions
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding; females of childbearing potential must have a negative pregnancy test and use effective birth control unless postmenopausal, surgically sterile, or with a vasectomized partner
  • Severe active inflammatory bowel disease (clinical remission allowed)
  • Severe kidney failure with eGFR less than 30 ml/min/1.73 m2
  • Severe heart failure classified as NYHA Class III or IV
  • Severe anemia with hemoglobin 8 g/dl or less
  • Chronic liver disease Child-Pugh class B or C
  • Electrolyte imbalances outside normal ranges
  • Significant abnormal baseline blood chemistry
  • Recent symptomatic acute ischemic heart disease within 6 months
  • History of major gastrointestinal surgeries affecting colon structure or function
  • History of gut paralysis (ileus)
  • Disorders of gastric emptying such as gastroparesis
  • Phenylketonuria (due to aspartame in study drug)
  • Glucose-6-phosphate dehydrogenase deficiency (due to ascorbate)
  • History of toxic megacolon
  • Use of laxatives or colon motility altering drugs within 24 hours before colonoscopy
  • Suspected bowel obstruction or perforation
  • Need for partial colonoscopy
  • Use of investigational drugs or therapies within 5 half-lives before study
  • Allergy to study drug ingredients
  • Underwater colonoscopy instead of standard gas insufflation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Hopital Erasme

Anderlecht, Belgium, 1070

Actively Recruiting

2

Katholieke Universiteit te Leuven

Leuven, Belgium, 3000

Actively Recruiting

3

Algemeen Ziekenhuis Damiaan Oostende

Ostend, Belgium, 8400

Actively Recruiting

4

Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi

Carpi, Modena, Italy, 41012

Actively Recruiting

5

Centro Di Riferimento Oncologico Di Aviano

Aviano, Pordenone, Italy, 33081

Actively Recruiting

6

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Verona, Italy, 37024

Actively Recruiting

7

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Bologna, Italy, 40138

Actively Recruiting

8

Fondazione Poliambulanza

Brescia, Italy, 25124

Actively Recruiting

9

Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce

Como, Italy, 22100

Actively Recruiting

10

Fondazione IRCCS Cà Granda Ospedale Policlinico

Milan, Italy, 20122

Actively Recruiting

11

Istituto Europeo di Oncologia

Milan, Italy, 20141

Actively Recruiting

12

Policlinico Universitario A. Gemelli

Roma, Italy, 00168

Actively Recruiting

13

Azienda Provinciale Per I Servizi Sanitari

Trento, Italy, 38122

Actively Recruiting

14

H-T.Centrum Medyczne Sp. z o.o. sp.k.

Tychy, Poland, 43-100

Actively Recruiting

15

Klinika Reuma Park Sp. z o.o. S.K.

Warsaw, Poland, 02-665

Active, Not Recruiting

16

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, Poland, 02-781

Actively Recruiting

17

Hospital Clinic De Barcelona

Barcelona, Spain, 08036

Actively Recruiting

18

Region Oerebro Laen

Örebro, Sweden, 701 85

Actively Recruiting

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Research Team

A

Alessandro Colombo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY) | DecenTrialz