Clinical trial · Interventional
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Adenomatous Polyp | Colorectal Adenomatous Polyp | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MiWEndo System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MiWEndo + colonoscope
- description
- All patients will be explored with MiWEndo as an accessory to colonoscopy
- interventionNames
- Device: MiWEndo System
Primary outcomes (3)
- measure
- Number of polyps
- timeFrame
- During the procedure.
- description
- With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
- measure
- Number of adverse events.
- timeFrame
- During the procedure and up to 2 weeks after.
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available