Clinical trial NCT05477836: Feasibility and Safety of MiWEndo-assisted Colonoscopy
Official title: Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Polyp
Colorectal Adenoma
Colorectal Neoplasms
Colorectal Adenomatous Polyp
Colorectal Adenocarcinoma
Keywords: microwave imaging
colonoscopy
early diagnosis
colorectal cancer screening
Lead sponsor: MiWEndo Solutions S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2022-07-28
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Traditional feasibility study, following a single-center prospective, non-comparative, with few patients design.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study involves the planned use of a new microwave-based device during colonoscopy procedures in a small group of patients to assess the preliminary safety of its use and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies, including: phantom studies, an ex vivo study with human tissues, and an in vivo study with animal model (pig).

Detailed description: This study is designed as a single-center prospective, non-comparative, first in human pilot safety and feasibility study with few patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis).

In this study the principal aim is to assess the clinical safety of the device and the feasibility of its use in assisted colonoscopy. Relevant claims to verify in this study are that the device can be used without ADEs, without any change in the current clinical practice, as well as without any major difficulty by the endoscopist, neither in the preparation nor in the use of the device during exploration.

In addition, the study aims to gather real clinical data with the use of the device to optimise the processing software that will be key to demonstrate MiWEndo's performance on a subsequent clinical investigation (pivotal study).

Consequently, principal and secondary objectives of this investigation, are:

* Principal objectives:

  * To assess the feasibility of performing a complete colonoscopy using the MiWEndo System.
  * To assess the safety of MiWEndo colonoscopy.
* Secondary objectives:

  * To assess the perception of difficulty by the endoscopist when the device is used.
  * To assess the patient's comfort.
  * To collect data on polyp detection performance to guide possible further improvements of the software before starting the pivotal study.

Eligibility criteria: Inclusion Criteria:

* Men and women older than 50 years referred for a diagnostic or surveillance colonoscopy and having signed the Informed Consent Form.

Exclusion Criteria:

* Patients at a high risk of having major complications as perforation or hemorrhage or in whom the possibility of performing a complete colonoscopy is reduced, including: patients with known colonic strictures, total colectomy, acute diverticulitis, inflammatory bowel disease, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing or previous incomplete colonoscopy.
* ASA-IV patients
* Urgent colonoscopy

Primary outcomes:
measure: Number of incidents and adverse events
timeFrame: During the procedure and up to 2 weeks after
measure: Number of mural injuries
timeFrame: During the procedure
measure: Rate of cecal intubation
timeFrame: During the procedure
measure: Length of colon explored
timeFrame: During the procedure
Secondary outcomes:
measure: Patients' comfort
timeFrame: Immediately after the procedure and 2 weeks after
measure: Time for reaching the cecum (or maximum explored colon length)
timeFrame: During the procedure
measure: Total time for completing the procedure
timeFrame: Immediately after the procedure
measure: Perception of difficulty
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
References: