Hernia
Conditions
Keywords
Fascia Closure Device, hernia,
Brief summary
The use of the TroClose1200™ will be done in at least one 12mm planned access port per the TroClose1200™ Instruction for Use. The procedure will be performed routinely. Adverse Events and device malfunctions, if any, will be recorded. Subjects will be hospitalized in accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days), at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit, the hernia signs will be evaluated by ultrasound.
Detailed description
Subjects that sign the Informed Consent Form will be evaluated for eligible for the study per eligibility criteria. Subject medical background and underlying disease requiring intervention will be taken at screening. Procedure will be scheduled. Subjects that will eventually, for any reason, will not be operated with the TroClose1200™, will be considered as screen failures. The use of the TroClose1200™ will be done in at least one 12mm planned access port per the TroClose1200™ Instruction for Use. The procedure will be performed routinely. Duration of use of the TroClose1200™ each time it is used will be measured, as well as the entire procedure duration, and the type of procedure. Adverse Events and device malfunctions, if any, will be recorded. The video seen in the monitors during the procedure will be kept as source data for any further analysis. The location of the TroClose1200™ used, as well as the other trocars used location, will be drawn on a special chart. Subjects will be hospitalized in accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days), at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit, the hernia signs will be evaluated by ultrasound.
Interventions
DEVICETroClose1200(TM)
Creation of access port and closure it by the same device, TroClose1200(TM)
Sponsors
Gordian Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome is the proportion of successfully created ports and their closure by the TRoClosed | Perioperative | Operator will record trocar insertion, anchor deployment, ability to accommodate laparoscopic surgical tools within the cannula and closure ability of the port for each of the ports created by the TroClose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy outcome assessed by hernia signs at 6,12,and 24 months | Up to 2 years | Hernia signs assessment by palpation by the surgeon at 6 weeks. Hernia signs assessment by palpation by the surgeon and by US at 12 months. Hernia signs assessment by palpation by the surgeon and by US at 24 months. |
| Secondary Safety Outcome assessed by surgical complications | up to 6 weeks | Surgical complication by Clavien Dindo classification perioperatively and at 6 weeks |
Countries
Israel
Contacts
Primary ContactHagar Mizrahi, Dr.
Outcome results
None listed