utility study of a predictive system for ambulatory colonoscopy preparation

Phase IV clinical trial for evaluating the utility in clinical practice of a predictive system of incorrect colonic preparation in patients derived for ambulatory colonoscopy

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000787-15-ES

Enrollment

300

Registered

2017-06-22

Start date

2017-08-02

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopia ambulatoria

Interventions

Trade Name: moviprep Product Name: moviprep Product Code: 68125 Pharmaceutical Form: Coated granules in sachet INN or Proposed INN: MACROGOL 3350 CAS Number: 25322-68-3 Current Sponsor code: MACROGOL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 18-85 years old Ambulatory candidates to colonoscopy Informe consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: colonic or small bowel resection, gastroparesia, pseudo obstruction, megacolon, bowel perforation, uncontrolled hypertension, CCI, CKF, pregnants, knowed hypersensibility to components, dementia with dysphagia, previous inclusión in the study, Boston scale under 6points in previous test

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare teh efficacy of two stategies of colonic preparation ;Secondary Objective: 1) Evaluate the utility of a system to allocate strategies for colonic preparation for colonoscopy 2) To compare the level of tolerance between two types of colonic preparation 3) To compare the rate of detection of different types of polyps with two types of preparation;Primary end point(s): colonic preparation with Boston scale;Timepoint(s) of evaluation of this end point: during coloscopy	—

Measure

Time frame

Main Objective: To compare teh efficacy of two stategies of colonic preparation ;Secondary Objective: 1) Evaluate the utility of a system to allocate strategies for colonic preparation for colonoscopy 2) To compare the level of tolerance between two types of colonic preparation 3) To compare the rate of detection of different types of polyps with two types of preparation;Primary end point(s): colonic preparation with Boston scale;Timepoint(s) of evaluation of this end point: during coloscopy

—

Secondary

Measure	Time frame
Secondary end point(s): tolerance, predisposition to repeat, swelling difficulties, detection of colonic lesions;Timepoint(s) of evaluation of this end point: colonoscopy	—

Countries

Spain

Contacts

Public ContactMagali Gonzalez-Colaço Harmand

Hospital Universitario de Canarias

magaligch@hotmail.com34922678115

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 15, 2026