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Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

Primary Purpose

Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MiWEndo System
Sponsored by
MiWEndo Solutions S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring microwave imaging, colonoscopy, early diagnosis, colorectal cancer screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with previously resected polyps. Patients with hereditary polyposis syndromes. Patients with Lynch Syndrome. Patients with familial cancer. These criteria will ensure the probability of finding polyps during the explorations. All the patients will give written informed consent. 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 or partial colectomy, acute diverticulitis, abdominal surgery, 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MiWEndo + colonoscope

    Arm Description

    All patients will be explored with MiWEndo as an accessory to colonoscopy

    Outcomes

    Primary Outcome Measures

    Number of polyps
    With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
    Number of adverse events.
    Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).
    Number of mural injuries.
    Mural injuries related with the use of the MiWEndo.

    Secondary Outcome Measures

    Rate of cecal intubation (yes/no).
    As a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy on the normal clinical practice, this parameter will be measured as complete colonoscopy (yes/no). In case cecum could not be reached, the distance reached will be measured (either in cm or anatomically, indicating what segment of the colon has been reached).
    Length of colon explored (cm).
    In case cecum could not be reached, the distance will be measured (in cm).
    Time reaching cecum and completing (min). Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
    Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice. Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
    Number and size (adenomas and polyps).
    The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.
    True positives (TP), False positives (FP), False negatives (FN).
    The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).
    Patients' comfort.
    Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).
    Perception of difficulty.
    Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).

    Full Information

    First Posted
    August 1, 2023
    Last Updated
    August 9, 2023
    Sponsor
    MiWEndo Solutions S.L.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05988645
    Brief Title
    Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
    Official Title
    Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    September 22, 2023 (Anticipated)
    Study Completion Date
    September 22, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MiWEndo Solutions S.L.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps 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 porcine model) and in a pilot study in humans (NCT05477836)
    Detailed Description
    This study is designed as a single-center prospective, non-comparative study in 50 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 aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims to verify in this study are that the device will detect in first instance polyps not detected initially with the endoscopic image and 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, in the first phase of the study (n=15 patients), 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 the second part of the study (n=35 patients). Consequently, principal and secondary objectives of this investigation, are: Principal objectives: To assess the performance of MiWEndo-assisted colonoscopy in the detection of colorectal polyps. To assess the safety of MiWEndo-assisted colonoscopy. Secondary objectives: To assess the feasibility of performing a complete colonoscopy using the MiWEndo device. To assess the perception of difficulty by the endoscopist when the device is used. To assess the operator learning curve with MiWEndo-assisted colonoscopy to guide future recommendations for training. To provide exploratory analysis of differences in MiWEndo-assisted colonoscopy in different groups of patients to guide future RCT. To assess the patient's comfort.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma, Colorectal Neoplasms
    Keywords
    microwave imaging, colonoscopy, early diagnosis, colorectal cancer screening

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MiWEndo + colonoscope
    Arm Type
    Experimental
    Arm Description
    All patients will be explored with MiWEndo as an accessory to colonoscopy
    Intervention Type
    Device
    Intervention Name(s)
    MiWEndo System
    Intervention Description
    All colonoscopies will be performed with high-definition technology. The MiWEndo System 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. The MiWEndo Analyzer will be managed by the assistant. At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headphones on (blind to the results of 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 Outcome Measure Information:
    Title
    Number of polyps
    Description
    With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
    Time Frame
    During the procedure.
    Title
    Number of adverse events.
    Description
    Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).
    Time Frame
    During the procedure and up to 2 weeks after.
    Title
    Number of mural injuries.
    Description
    Mural injuries related with the use of the MiWEndo.
    Time Frame
    During the procedure and up to 2 weeks after.
    Secondary Outcome Measure Information:
    Title
    Rate of cecal intubation (yes/no).
    Description
    As a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy on the normal clinical practice, this parameter will be measured as complete colonoscopy (yes/no). In case cecum could not be reached, the distance reached will be measured (either in cm or anatomically, indicating what segment of the colon has been reached).
    Time Frame
    During procedure.
    Title
    Length of colon explored (cm).
    Description
    In case cecum could not be reached, the distance will be measured (in cm).
    Time Frame
    During the procedure.
    Title
    Time reaching cecum and completing (min). Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
    Description
    Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice. Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
    Time Frame
    During procedure.
    Title
    Number and size (adenomas and polyps).
    Description
    The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.
    Time Frame
    During procedure.
    Title
    True positives (TP), False positives (FP), False negatives (FN).
    Description
    The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).
    Time Frame
    During procedure.
    Title
    Patients' comfort.
    Description
    Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).
    Time Frame
    Immediately after the procedure and 2 weeks after.
    Title
    Perception of difficulty.
    Description
    Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).
    Time Frame
    Immediately after the procedure.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with previously resected polyps. Patients with hereditary polyposis syndromes. Patients with Lynch Syndrome. Patients with familial cancer. These criteria will ensure the probability of finding polyps during the explorations. All the patients will give written informed consent. 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 or partial colectomy, acute diverticulitis, abdominal surgery, 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

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