CholecystolithiasisNCT06036303
Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery
A study testing Nasr fascial closure device and Berci Fascial Closure Device in people with Cholecystolithiasis, run by ClinAmygate at 1 site in Egypt.
Trial summary
The study will investigate the efficacy and safety of a new fascial closure device "Nasr Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- Nasr fascial closure device and Berci Fascial Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to 15 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18
- eligible for Laparoscopic cholecystectomy
Who cannot join
- refused to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān
Mohie El-Din M Madany, MD, 01141341342, Mohie.madany@med.aswu.edu.eg
Mohie El-Din M Madany, MD
About this study
The study will investigate the efficacy and safety of a new fascial closure device "Nasr Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM.
- Conditions
- Cholecystolithiasis
- Being tested
- Nasr fascial closure device, Berci Fascial Closure Device
- Keywords
- Laparoscopic removal
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasr fascial closure deviceDevice
Nasr fascial closure device is a novel device for fascial closure
Berci Fascial Closure DeviceDevice
Berci Fascial Closure Device is a known device for fascial closure
| Study group | Role | What they receive |
|---|---|---|
| Nasr Fascial Closure Device | Experimental | Not described Receives: Device: Nasr fascial closure device |
| Berci Fascial Closure Device | Active comparator | Not described Receives: Device: Berci Fascial Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of port site closure
Duration in seconds
Measured: 1 day
Rate of failure of port site
Rate of failure to close the port site
Measured: 1 day
Secondary outcomes (2)
Incidence of port site infection
Incidence of infection of the port site
Measured: 1 month
Incidence of port site hernia
Incidence of hernia at the port site
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Sep 2023
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystolithiasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University Hospital
- Responsible party
- Sponsor
- Investigators
- Mohie El-Din M Madany, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036303
- Sponsor's protocol ID
- PR00C1945
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06036303
- Acronym / sponsor ID
- PR00C1945
- Conditions
- Cholecystolithiasis
- Keywords
- Laparoscopic removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Collaborators
- Aswan University Hospital
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 13 Sep 2023 (actual)
- 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 study will investigate the efficacy and safety of a new fascial closure device "Nasr Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasr Fascial Closure Device | Experimental | Device: Nasr fascial closure device |
| Berci Fascial Closure Device | Active comparator | Device: Berci Fascial Closure Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18
- eligible for Laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- refused to participate
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 |
|---|---|---|
| Nasr fascial closure deviceNasr fascial closure device is a novel device for fascial closure | Device | Nasr Fascial Closure Device |
| Berci Fascial Closure DeviceBerci Fascial Closure Device is a known device for fascial closure | Device | Berci Fascial Closure Device |
Primary outcome
duration of port site closure
Time frame: 1 day
Duration in seconds
Rate of failure of port site
Time frame: 1 day
Rate of failure to close the port site
2 secondary outcomes
Incidence of port site infection
Time frame: 1 month
Incidence of port site hernia
Time frame: 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 Sep 2023.
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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.
Mohie El-Din M Madany principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasr fascial closure device and Berci Fascial Closure Device in people with Cholecystolithiasis, run by ClinAmygate at 1 site in Egypt.
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 2 inclusion and 1 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 Sep 2023. 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 Egypt. 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 Mohie El-Din M Madany, MD (01141341342, Mohie.madany@med.aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of port site closure (time frame: 1 day). The study lists 2 primary outcomes in all. 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 Sep 2023.