Evaluation of the Performance of the Motus Cleansing System (MCS)

M

Motus GI

Status

Completed

Conditions

CRC

Treatments

Device: Motus Cleansing System (MCS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03026075
CL00016

Details and patient eligibility

About

The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.

Full description

Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands). Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure. Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).

Enrollment

47 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects being considered for diagnostic, screening or surveillance colonoscopy
  • Subjects in the age range of 18-75 years inclusive
  • Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
  • Subject has signed the informed consent

Exclusion criteria

  • Subjects with known Inflammatory Bowel Disease
  • Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
  • Subjects with known or detected (during colonoscopy) bowel obstruction
  • History of prior surgery to colon and/or rectum
  • ASA≥IV
  • Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
  • Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
  • Subjects taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
  • Subjects with known coagulation disorder (INR >1.5).
  • Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
  • Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
  • Subjects with known Mega Colon
  • Pregnancy (as stated by patient) or breast feeding
  • Subjects with altered mental status/inability to provide informed consent
  • Patients who have participated in another interventional clinical study in the last 2 months

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

47 participants in 1 patient group

Colonoscopy with MCS
Experimental group
Description:
Standard colonoscopy procedure with Motus Cleansing System
Treatment:
Device: Motus Cleansing System (MCS)

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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