Clinical Trial: Motorized Spiral Colonoscopy Trial: A First Feasibility Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Motorized Spiral Colonoscopy Trial (MSCT): A First Feasibility Trial

Brief Summary: The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy.

Detailed Summary:

Colonoscopy has been widely accepted for the diagnosis and treatment of colon diseases. Properly performed, colonoscopy is generally safe, accurate, and well-tolerated. Diagnostic colonoscopy is the preferred method to evaluate the colon in most patients with large-bowel symptoms, iron deficiency anemia, abnormal results on radiographic studies of the colon, positive results on colorectal cancer (CRC) screening tests, post-polypectomy and post-cancer resection surveillance, and diagnosis and surveillance in inflammatory bowel disease. In addition, colonoscopy has been introduced for CRC screening in some Western countries e.g. in the United States and Germany. Recent trials showed that screening colonoscopy has a large potential for prevention and early detection of colorectal cancer. Diagnostic colonoscopy is usually combined with endoscopic resection of small and medium sized polyps and flat neoplastic lesions. Patients in whom larger lesions are detected at a diagnostic colonoscopy are usually rescheduled for therapeutic colonoscopy in an appropriate setting.

Quality parameters for colonoscopy were recently reported. In terms of intraprocedural indicators a cecal intubation rate of ≥ 90% for all cases of colonoscopy is widely accepted. Even experienced endoscopists classify up to 10% of colonoscopies as difficult and intubation of the cecum may then be impossible. A recent study evaluated the efficacy and safety of repeating colonoscopy in 520 patients with prior incomplete colonoscopy. Reasons for failure to complete colonoscopy in referring institutions were "looping/redundant colon" in 53.8% of the cases, "sigmoid fixation/angulation" in 38.8%, "both sigmoid angulation and looping colon" in 5.8% of the cases. Issues with sedation caused failures in 1.5% of the patients. Conventional colonoscopy can be difficult in particular in th
Sponsor: Evangelisches Krankenhaus Düsseldorf

Current Primary Outcome: Cecal intubation rate [ Time Frame: 3 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ileum intubation rate [ Time Frame: 3 days ]
  • Procedure time [ Time Frame: 3 days ]
  • rate of need for external compression [ Time Frame: 3 days ]
    external compression necessary during intervention, yes/no?
  • adenoma detection rate [ Time Frame: 3 days ]
  • success rate for removal of polyps [ Time Frame: 3 days ]
  • amount of propofol needed for sedation [ Time Frame: 3 days ]
  • maximum level of sedation during procedure [ Time Frame: 3 days ]
    sedation depth assessed by ESGE-guideline, level 1-3
  • patient satisfaction score [ Time Frame: 3 days ]
    1-10 visual analog scale
  • adverse event rate [ Time Frame: 3 days ]
  • maximum pain during procedure [ Time Frame: 3 days ]
    1-10 visual analog scale


Original Secondary Outcome: Same as current

Information By: Evangelisches Krankenhaus Düsseldorf

Dates:
Date Received: December 15, 2016
Date Started: December 2016
Date Completion: February 2017
Last Updated: December 19, 2016
Last Verified: December 2016