Clinical trial NCT05988645: 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
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Colorectal Polyp
Colorectal Adenoma
Colorectal Adenomatous Polyp
Colorectal Adenocarcinoma
Colorectal Neoplasms
Keywords: microwave imaging
colonoscopy
early diagnosis
colorectal cancer screening
Lead sponsor: MiWEndo Solutions S.L.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.
Primary purpose: DIAGNOSTIC

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\&#39;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 perception of difficulty by the endoscopist when the device is used.
* 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.

Eligibility criteria: Inclusion Criteria:

- Patients with a previously detected polyp in the rectum referred for resection.

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, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
* ASA-IV patients.
* Urgent colonoscopy.

Primary outcomes:
measure: Number of polyps
timeFrame: During the procedure.
measure: Number of adverse events.
timeFrame: During the procedure and up to 2 weeks after.
measure: Number of mural injuries.
timeFrame: During the procedure and up to 2 weeks after.
Secondary outcomes:
measure: Number and size (adenomas and polyps).
timeFrame: During procedure.
measure: True positives (TP), False positives (FP), False negatives (FN).
timeFrame: During procedure.
measure: Patients' comfort.
timeFrame: Immediately after the procedure and 2 weeks after.
measure: Perception of difficulty.
timeFrame: Immediately after the procedure.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: