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Completed

NCT Number: NCT05477836

Feasibility and Safety of MiWEndo-assisted Colonoscopy

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Adenocarcinoma Colorectal Adenoma Colorectal Adenomatous Polyp Colorectal Neoplasms Colorectal Polyp Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MiWEndo-assisted colonoscopy

Device

All colonoscopies will be performed with high-definition technology. The MiWEndo System (MiWEndo Solutions, Barcelona) will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System.

At the beginning of the extubation, the MiWEndo System will be turned on. During extubation, each segment will be carefully examined with both white light and MiWEndo. In case one of them identifies a polyp, the exploration will be stopped and check if it has been detected by the alternative method as well. All the polyps will be resected and sent to the Pathological Department for histological analysis following the usual clinical practice. A stopwatch will be used to measure both total procedure time and withdrawal time.

Primary outcomes

  1. Number of incidents and adverse events

    Time frame: During the procedure and up to 2 weeks after

    To assess the safety of MiWEndo colonoscopy using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE).

  2. Number of mural injuries

    Time frame: During the procedure

    To assess the safety of MiWEndo colonoscopy according to the Sydney classification for deep mural injuries (DMI)

  3. Rate of cecal intubation

    Time frame: During the procedure

    To assess the feasibility of performing a complete colonoscopy using the MiWEndo System. This parameter will be measured as complete colonoscopy (yes/no).

  4. Length of colon explored

    Time frame: During the procedure

    In case cecum could not be reached, the distance will be measured (in cm).

Secondary outcomes

  1. Patients' comfort

    Time frame: Immediately after the procedure and 2 weeks after

    Subjective assessment from patient following the Gloucester 5-Likert scale, where 1 is no discomfort and 5 is extreme discomfort.

  2. Time for reaching the cecum (or maximum explored colon length)

    Time frame: During the procedure

    Measured in minutes

  3. Total time for completing the procedure

    Time frame: Immediately after the procedure

    Measured in minutes

  4. Perception of difficulty

    Time frame: Immediately after the procedure

    Difficulty by the endoscopist subjectively assessed based on a 5-points Likert scale, where 0 is not difficult and 4 is very difficult.

Sponsors and collaborators

Lead sponsor

MiWEndo Solutions S.L.

Industry

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study title

Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study

Acronym: MiWEndo1

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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