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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT02746653 |
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Date of registration:
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12/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness and Safety of Gordian Surgical's TroClose1200™
GOR-CLN-01 |
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Scientific title:
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Effectiveness and Safety of Gordian Surgical's TroClose1200™, a Trocar With built-in Closure Device Capability, in Subjects Undergoing Laparoscopic Surgery |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02746653 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Hagar Mizrahi, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Hagar Mizrahi, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Poryia Medical Center, Israel |
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Name:
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Hagar Mizrahi, Dr. |
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Address:
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Telephone:
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+972 52 3469739 |
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Email:
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hagarmizrahi@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subject is = 18 years old and less than 65 years.
2. Subject is a candidate for laparoscopic surgery with at least one 12 mm trocar is to
be used apart from the endoscopic access port.
3. Subject is capable and willing to comply with, and be present at, the follow-up
clinic visits of the 6 weeks visit.
4. Subject is able and willing to sign a written informed consent form.
Exclusion Criteria:
1. Patients presenting factors that affect the scarring process, such as malnutrition
(serum proteins <5 g/dl or Albumin below 3 g/dl).
2. Advanced cancer.
3. Perioperative hemodynamic instability
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hernia
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Intervention(s)
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Device: TroClose1200(TM)
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Primary Outcome(s)
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Primary Outcome is the proportion of successfully created ports and their closure by the TRoClosed
[Time Frame: Perioperative]
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Secondary Outcome(s)
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Secondary Safety Outcome assessed by surgical complications
[Time Frame: up to 6 weeks]
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Secondary efficacy outcome assessed by hernia signs at 6,12,and 24 months
[Time Frame: Up to 2 years]
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Secondary ID(s)
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GOR-CLN-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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