CompletedNot Applicable

Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD

Italy15 participantsStarted 2023-03-14

Plain-language summary

The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis of superficial neoplastic lesion to be resected by a gastrointestinal endoscopic resection (EMR or ESD) * Older than 18 years of age at time of consent; * Operable per institution's standards; * Signed and dated informed consent form Exclusion Criteria: * Any clinical conditions precluding the feasibility of gastrointestinal endoscopic resection (ENDONEB could be contraindicated in patients who are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment); * Pregnant during period of study participation; * Allergy history to cyanoacrylate.

What they're measuring

Evaluate the feasibility of the technique

Timeframe: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

Evaluate the feasibility of the technique

Timeframe: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

Trial details

NCT IDNCT06588881

SponsorGEM SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-28

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