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Clinical Trials in Spain / NCT05988645
Recruiting Not applicable

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

NCT05988645 · tracked via the Priya Life Science Spain tracker
Sponsor
MiWEndo Solutions S.L
Phase
Not applicable
Started
2023-08-01
Last updated
2026-10-08

Condition(s) studied

Colorectal CancerColorectal PolypColorectal AdenomaColorectal Adenomatous PolypColorectal AdenocarcinomaColorectal Neoplasms

Investigational drug(s) / intervention(s)

MiWEndo System

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 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.

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: \- Patients older than 18-year-old referred for a screening or surveillance colonoscopy because of a high-risk condition of developing colorectal cancer or having colorectal polyps as fecal occult blood test (FOBT) positive, previously resected polyps under surveillance, hereditary polyposis syndromes, Lynch Syndrome or 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, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing. * ASA-IV patients. * Urgent colonoscopy.

Primary outcome measure(s)

  • Number of polyps — During the procedure.
    With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
  • Number of adverse events. — During the procedure and up to 2 weeks after.
    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. — During the procedure and up to 2 weeks after.
    Mural injuries related with the use of the MiWEndo.

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinic Barcelona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05988645 on ClinicalTrials.gov ↗ ← All trials in Spain