Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MiWEndo System.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
Overview
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 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.
Interventions
- Device MiWEndo System
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 headp
Primary outcome measures
- Number of polyps [Time frame: During the procedure.]
- Number of adverse events. [Time frame: During the procedure and up to 2 weeks after.]
- Number of mural injuries. [Time frame: During the procedure and up to 2 weeks after.]
Secondary outcome measures (4)
- Number and size (adenomas and polyps). [Time frame: During procedure.]
- True positives (TP), False positives (FP), False negatives (FN). [Time frame: During procedure.]
- Patients' comfort. [Time frame: Immediately after the procedure and 2 weeks after.]
- Perception of difficulty. [Time frame: Immediately after the procedure.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Spain · 1 center
- Hospital Clinic — Barcelona
Identifiers
NCT: NCT05988645 · MW II-CIP