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NCT Number: NCT03756636

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

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

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Key information

Conditions

Colo-rectal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Macroscopically complete resection rate

    Time frame: 6 Months

  2. 6-month recurrence rate;

    Time frame: 6 Months

  3. Rate of adverse events (according to the lexiconA ASGE).

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: UEMREleview

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2018
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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