Abdominal Wall DefectSAFIL_MESHNCT04947202
Clinical Study on the Safety of SAFIL® MESH
An observational study of Abdominal Wall Defect and Ventral Hernia, run by Aesculap AG at 2 sites in Spain.
Trial summary
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Wall Defect, Ventral Hernia, Abdominal Hernia
- What is being tested?
- Hernioplasty
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jul 2021to 30 Nov 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
Who may be able to join
- Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
Who cannot join
- No exclusion criteria have been set.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Galdakao-Usansolo
Galdakao, Bizkaia, 48960
Hospital Universitario de Salamanca
Salamanca, 37007
About this study
Official title: Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
Read the detailed description
The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020
- Being tested
- Hernioplasty
- Keywords
- Reinforcement of Soft Tissues, Hernioplasty, mesh repair
- Medical subject headings
- Hernia, Ventral, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HernioplastyDevice
Hernioplasty is the repair of the defect using mesh patches.
| Study group | Role | What they receive |
|---|---|---|
| Safil Mesh | Not described Receives: Device: Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia rate
Rate of hernias occuring during follow-up of retrospectively included patients
Measured: at one follow-up 12-30 months after initial intervention
Secondary outcomes (3)
Intra-operative complications
Retrospective documentation of Number of Participants with intraoperative Complications
Measured: intraoperatively
Post-operative complications
Number of retrospectively included participants having complications during follow-up of
Measured: at one follow-up 12-30 months after initial intervention
Reintervention rate
Complications leading to reintervention during follow-up of retrospectively included patients
Measured: at one follow-up 12-30 months after initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall DefectStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Izaskun Badiola Bergara, Dr., Principal investigator, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947202
- Sponsor's protocol ID
- AAG-O-H-2040
- Acronym
- SAFIL_MESH
- Status last verified
- Jan 2022
- First submitted
- 16 Jun 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
- ClinicalTrials.gov ID
- NCT04947202
- Acronym / sponsor ID
- SAFIL_MESH / AAG-O-H-2040
- Keywords
- Reinforcement of Soft Tissues, Hernioplasty, mesh repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Jul 2021 (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.
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
Detailed description
The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safil Mesh | – | Device: Hernioplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
Key inclusion criteria (1 listed)
- Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
Key exclusion criteria (1 listed)
- No exclusion criteria have been set.
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 |
|---|---|---|
| HernioplastyHernioplasty is the repair of the defect using mesh patches. | Device | Safil Mesh |
Primary outcome
Hernia rate
Time frame: at one follow-up 12-30 months after initial intervention
Rate of hernias occuring during follow-up of retrospectively included patients
3 secondary outcomes
Intra-operative complications
Time frame: intraoperatively
Post-operative complications
Time frame: at one follow-up 12-30 months after initial intervention
Reintervention rate
Time frame: at one follow-up 12-30 months after initial intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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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.
Izaskun Badiola Bergara, Dr. principal investigator
Hospital Galdakao-Usansolo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wall Defect and Ventral Hernia, run by Aesculap AG at 2 sites in Spain.
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 1 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: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia rate (time frame: at one follow-up 12-30 months after initial intervention). 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 24 Jan 2022.