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Underwater Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.

Underwater Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03756636
Acronym
UEMREleview
Enrollment
40
Registered
2018-11-28
Start date
2018-06-01
Completion date
2018-11-26
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Polyps

Brief summary

All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract. Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure. Any bleeding (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born complication. A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure

Interventions

PROCEDUREUnderwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

Underwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age\> 18 years. * Signing of informed consent. * Possibility of being subjected to the diagnostic and therapeutic procedures of the study. * Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of fibrosis as a consequence of previous incomplete treatments or biopsies or relapses after previous removal.

Exclusion criteria

* Highly indicative morphological characteristics of carcinoma with submucosal invasion (Ulceration, Pit Pattern Vn according to Kudo et al.18) * Pregnancy or breastfeeding * ASA\> 3 * Unstable personality or unable to adhere to the protocol procedures. * Inability to provide informed consent. * Injury not reachable endoscopically.

Design outcomes

Primary

MeasureTime frame
Macroscopically complete resection rate6 Months
6-month recurrence rate;6 Months
Rate of adverse events (according to the lexiconA ASGE).6 Months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026