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Seal-G / Seal-G MIST Study

NCT04532515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-12-11

No results posted yet for this study

Summary

A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery

Conditions

Interventions

DEVICE

Seal-G Surgical Sealant

Seal-G is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis

DEVICE

Seal-G MIST System

Seal-G MIST is a surgical sealant intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosis

Sponsors & Collaborators

  • ClinSearch

    collaborator OTHER

  • Advanced Medical Solutions Israel (Sealantis) Ltd.

    collaborator UNKNOWN

  • Advanced Medical Solutions Ltd.

    lead INDUSTRY

Principal Investigators

  • Moshe Kamar, MD · Advanced Medical Solutions Israel (Sealantis) Ltd.

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-07-25
Completion
2023-10-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532515 on ClinicalTrials.gov