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Completed

NCT Number: NCT06588881

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

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

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

About this study

Single center, prospective, medical device usability and feasibility study. The study will be performed in Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome.

According to the recomandations of the Italian Ministry of Health (28) regarding the sample size of pilot and feasibility studies, 15 applications underwent to mucosal or submucosal resection procedures will be evaluated. The recruitment period will be 36 weeks (9 months). The evaluation ends when ENDONEB has been used in the fifteenth subject or at one third of applications if the investigators will be able to give their evaluation of the feasibility of the ENDONEB technique, usability and safety. The ENDONEB medical device belongs to the family of "Nebulizers" class IIa accessory devices, used to apply Glubran®2 in nebulized form in laparotomic, laparoscopic and thoracoscopic procedures. The ENDONEB medical device allows to apply the Glubran®2 in nebulized form in digestive endoscopy interventions and can be used both with gastroscopes and colonoscopes with an operating channel not less than 2.6 mm. It is marketed in sterile presentation; the components are latex free and is for single use only.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection

Device

ENDONEB, a nebulizing catheter containing the synthetic haemostatic-sealant Glubran®, is inserted in the operative channel of the endoscope until it is pushed out of the endoscope tip approximately 2 cm. The haemostatic-sealant is nebulized over the surface of the post resection mucosal defect by activating the propellant (medical-inert-gas) container. An amount of about 0.3 mL of Glubran® 2 (or more - depending on dimension of the lesion) is applied on mucosal or sub-mucosal defect in order to create a proper haemostaticsealant film.

Primary outcomes

  1. Evaluate the feasibility of the technique

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

    Appropriateness of ENDONEB medical nebulizer device to apply the surgical haemostatic-sealant Glubran® 2 after gastrointestinal endoscopic resections evaluated in terms of positioning correctly the ENDONEB device for procedure as per the user manual's instructions. The outcome is measured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

  2. Evaluate the feasibility of the technique

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

    Appropriateness of ENDONEB medical nebulizer device to apply the surgical haemostatic-sealant Glubran® 2 after gastrointestinal endoscopic resections evaluated in terms of facility of use and satisfaction/effectiveness of the surgeon. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

Secondary outcomes

  1. Evaluate the ENDONEB Usability and Safety

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

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the facility to assembly the device (setting up time, easiness in assembly, single operator assembly). Each point is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

  2. Evaluate the ENDONEB Usability and Safety

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

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the ability to deliver the haemostatic-sealant to the resection site. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

  3. Evaluate the ENDONEB Usability and Safety

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

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the ability to use the device through the endoscope. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

  4. Evaluate the ENDONEB Usability and Safety

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

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the duration of the procedure to use the device (time). The outcome is mesaured in minutes.

  5. Evaluate the ENDONEB Usability and Safety

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

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • ease of use in terms of capacity to control and manage the device. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

  6. Evaluate the ENDONEB Usability and Safety

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

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • any technical complications during the procedure of application. The evaluation of this outcome is a detailed description of the technical complications that occurred.

  7. Evaluate the ENDONEB Usability and Safety

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

    Safety assessment will be performed by verifying any episodes of device malfunction during the entire application such as:

    • failure or breakage of the device. The measure of this outcome is reported with a detailed description of the event.

  8. Evaluate the ENDONEB Usability and Safety

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

    Safety assessment will be performed by verifying any episodes of device malfunction during the entire application such as:

    • lengthening of application times due to obstruction of the catheter or obstruction of the operating channel. The outcome is measured with a score from 1 to 5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

Sponsors and collaborators

Lead sponsor

GEM SRL

Industry

Registry information

Official study title

A Pilot Study on Feasibility of Technique, Performance and Safety of ENDONEB Endoscopic Medical Device for the Nebulized Application of the Haemostatic Surgical Sealant After Gastrointestinal Endoscopic Resection

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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