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N/A N=38 Diagnostic

Endorail in Long Lasting Colonoscopy

Colonoscopy · Incomplete Colonoscopy

Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Incomplete Long-lasting Colonscopies — 0 % of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ENDORAIL (Device)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Endostart srl
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Incomplete Long-lasting Colonscopies
PRIMARY
Number of Device-related Serious Adverse Events
PRIMARY
Number of Device-related Serious Adverse Events

Summary

Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Endorail works as a magnetic anchor that is able to guide the colonoscope and to straighten colon curves and loops. The aim of this study is to test the safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75 years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time greater than 10 minutes will take part in the study. The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety endpoints are the absence of device-related serious adverse events and the evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.

Eligibility Criteria

Inclusion Criteria

  • Patients of both sexes aged between 22 - 75 years (inclusive);
  • Outpatients undergoing long-lasting diagnostic and surveillance colonoscopy; long-lasting colonoscopy is defined as follows: colonoscopy completion (caecal intubation) not achieved after 10 minutes from endoscope insertion through the anal canal;
  • Patients have given a written informed consent for participation in the study at the time of enrolment or before;
  • Patients able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation based on Investigator's judgement.

Exclusion Criteria

  • Body mass index (BMI) > 30 kg/m2;
  • Outpatients undergoing colonoscopy for colorectal cancer screening or therapeutic indication;
  • Patients in class >2 physical status of the classification system of American Society of Anaesthesiologists;
  • Any contraindications to colonoscopy;
  • Any contraindications to sedation;
  • Known allergy or hypersensitivity to any of the elements of the Endorail Set (e.g.: iron);
  • Patients with permanently or semi-permanently implanted medical devices, (e.g. orthopedic implants, trauma fixation devices, cardiac pacemakers, implantable cardioverter defibrillator, drug pumps, neurostimulators, vascular stents, cochlear implants, aneurysm clip);
  • Presence of dense diverticulosis
  • Presence of diverticulitis
  • Presence of ferromagnetic foreign body;
  • Presence of large abdominal hernias;
  • Presence of severe thrombocytopenia;
  • Presence of severe granulocytopenia;
  • Presence of severe coagulopathy;
  • Presence of peritonitis;
  • Presence of colonic wall ischemia or necrosis or injured mucosa;
  • Presence of peritoneal carcinomatosis;
  • Boston Bowel Preparation Scale <2 in at least one of the colonic segments;
  • Presence of obstructing masses and strictures of the colon;
  • History of total or subtotal colectomy.
  • Presence of angulated and fixed colon curves;
  • Pregnant or breast-feeding women;
  • Patient unable to provide the signed informed consent, uncooperative patient or patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
  • Presence of any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety
  • Concomitant participation in other clinical investigations or participation in the evaluation of any investigational product/device in the 30 days before this study or previous participation in the same investigation;
  • Urgent colonoscopy.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05626738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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