HerniaGOR-CLN-01NCT02746653
Effectiveness and Safety of Gordian Surgical's TroClose1200™
A study testing TroClose1200(TM) in people with Hernia, run by Gordian Surgical at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hernia
- What is being tested?
- TroClose1200(TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years old and less than 65 years.
- Subject is a candidate for laparoscopic surgery with at least one 12 mm trocar is to be used apart from the endoscopic access port.
- Subject is capable and willing to comply with, and be present at, the follow-up clinic visits of the 6 weeks visit.
- Subject is able and willing to sign a written informed consent form.
Who cannot join
- Patients presenting factors that affect the scarring process, such as malnutrition (serum proteins <5 g/dl or Albumin below 3 g/dl).
- Advanced cancer.
- Perioperative hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Poryia Medical Center
Teberias
Hagar Mizrahi, Dr.
Hagar Mizrahi
About this study
Official title: Effectiveness and Safety of Gordian Surgical's TroClose1200™, a Trocar With built-in Closure Device Capability, in Subjects Undergoing Laparoscopic Surgery
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.
Read the 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.
- Conditions
- Hernia
- Being tested
- TroClose1200(TM)
- Keywords
- Fascia Closure Device, hernia,
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TroClose1200(TM)Device
Creation of access port and closure it by the same device, TroClose1200(TM)
| Study group | Role | What they receive |
|---|---|---|
| Use of TroClose1200(TM) for access port and closure device | Experimental | TroClose in 1 port Receives: Device: TroClose1200(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome is the proportion of successfully created ports and their closure by the TRoClosed
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
Measured: Perioperative
Secondary outcomes (2)
Secondary efficacy outcome assessed by hernia signs at 6,12,and 24 months
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.
Measured: Up to 2 years
Secondary Safety Outcome assessed by surgical complications
Surgical complication by Clavien Dindo classification perioperatively and at 6 weeks
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gordian Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hagar Mizrahi, Dr., Principal investigator, Poryia Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746653
- Sponsor's protocol ID
- GOR-CLN-01
- Acronym
- GOR-CLN-01
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Gordian Surgical's TroClose1200™, a Trocar With built-in Closure Device Capability, in Subjects Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02746653
- Acronym / sponsor ID
- GOR-CLN-01 / GOR-CLN-01
- Conditions
- Hernia
- Keywords
- Fascia Closure Device, hernia,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gordian SurgicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of TroClose1200(TM) for access port and closure device | Experimental | Device: TroClose1200(TM)TroClose in 1 port |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is ≥ 18 years old and less than 65 years.
- Subject is a candidate for laparoscopic surgery with at least one 12 mm trocar is to be used apart from the endoscopic access port.
- Subject is capable and willing to comply with, and be present at, the follow-up clinic visits of the 6 weeks visit.
- Subject is able and willing to sign a written informed consent form.
Key exclusion criteria (3 listed)
- Patients presenting factors that affect the scarring process, such as malnutrition (serum proteins <5 g/dl or Albumin below 3 g/dl).
- Advanced cancer.
- Perioperative hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TroClose1200(TM)Creation of access port and closure it by the same device, TroClose1200(TM) | Device | Use of TroClose1200(TM) for access port and closure device |
Primary outcome
Primary Outcome is the proportion of successfully created ports and their closure by the TRoClosed
Time frame: 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
2 secondary outcomes
Secondary efficacy outcome assessed by hernia signs at 6,12,and 24 months
Time frame: Up to 2 years
Secondary Safety Outcome assessed by surgical complications
Time frame: up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagar Mizrahi, Dr. principal investigator
Poryia Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TroClose1200(TM) in people with Hernia, run by Gordian Surgical at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagar Mizrahi, Dr. (+972 52 3469739, hagarmizrahi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome is the proportion of successfully created ports and their closure by the TRoClosed (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.