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

NCT06588881 | Completed

• 1 other identifier: DGDMF/I.5.i.m.2/2022/2045
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate the feasibility of the technique

  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.

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

• Evaluate the feasibility of the technique

  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.

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

Secondary Outcomes (8)

• Evaluate the ENDONEB Usability and Safety

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

• Evaluate the ENDONEB Usability and Safety

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

• Evaluate the ENDONEB Usability and Safety

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

• Evaluate the ENDONEB Usability and Safety

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

• Evaluate the ENDONEB Usability and Safety

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

Study Arms (1)

ENDONEB

OTHER

The sterile device and gamma rays, latex free and disposable consists of the following components: a steel canister, a catheter 2m hose, one attack base located at the proximal end of the catheter, one unit at the end back, two needles and two syringes. The device must always be stored in the original packaging. Store only in one place Temp temperature not exceeding 30°C(86°)Application procedure: The device must be pr repaired and activated adequately in order to ensure its correctness operation. See instructions for assembly and indoor use of the package.

Device: nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection

Interventions

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.

ENDONEB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GEM SRL: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, Italy

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Cristiano Spada, DR

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, prospective, medical device usability and feasibility study.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: September 19, 2024
• Study Start: March 14, 2023
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)