Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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