Grade I Ventral HerniaPhase 4NCT02341430
A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh
A Phase 4 study testing Symbotex™ Composite Mesh in people with Grade I Ventral Hernia and Grade II Ventral Hernia, run by Anne Arundel Health System Research Institute at 1 site in United States.
Trial summary
This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade I Ventral Hernia, Grade II Ventral Hernia
- What is being tested?
- Symbotex™ Composite Mesh
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 31 Dec 2018
- Phase
- Phase 4
- 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 or older
- Grade I or II ventral hernia according to VHWG classification system
- Pre-operative informed consent is obtainable
Who cannot join
- Not candidate for laparoscopic approach for repair of their hernia
- Determination in the operating room that biologic mesh is needed over permanent mesh
- Fascial defect less than 3 cm in greatest dimension
- Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed
- Grade III or IV ventral hernia according to VHWG system
- ASA score IV or above
Show all 9Show fewer
- Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. These include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation.
- Pregnancy
- Use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. In other words, if the hernia defect is larger than the largest Symbotex™ mesh available, two or more Symbotex mesh pieces may be used to appropriately repair the hernia defect.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anne Arundel Medical Center
Annapolis, Maryland, 21401
About this study
This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.
Read the detailed description
This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.
- Conditions
- Grade I Ventral Hernia, Grade II Ventral Hernia
- Being tested
- Symbotex™ Composite Mesh
- Keywords
- hernia, synthetic mesh
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbotex™ Composite MeshDevice
Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence
Measured: One year
Quality of Life
Measured: One year
Hernia associated pain and movement limitations pre-surgery compared to post-surgery
Measured: One year
Reoperation Rate
Measured: One year
Percutaneous Intervention Rate
Measured: One year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2016
- Primary completion11 Sep 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Grade I Ventral 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Arundel Health System Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Adrian Park, M.D., Principal investigator, Anne Arundel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341430
- Sponsor's protocol ID
- 689069
- Status last verified
- Feb 2019
- First submitted
- 8 Jan 2015
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ventral Hernia Working Group; Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, Kilbridge JF, Rosen M, Silverman RP, Vargo D. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010 Sep;148(3):544-58. doi: 10.1016/j.surg.2010.01.008. Epub 2010 Mar 20.
PubMed 20304452Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.
PubMed 14501505SymbotexTM clinging effect observed during the design validation conducted by Covidien in porcine model in May 2013- covidien internal memorandum 0901CR261a (July 2013)
Malangoni MA and Rosen MJ. Chapter 46: Hernias, Sabiston Textbook of Surgery 19th Edition. Elsevier; Philadelphia, PA. 2012: 1128-1135
Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.
PubMed 18387468Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18.
PubMed 20404280
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh
- ClinicalTrials.gov ID
- NCT02341430
- Acronym / sponsor ID
- 689069
- Conditions
- Grade I Ventral Hernia, Grade II Ventral Hernia
- Keywords
- hernia, synthetic mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Anne Arundel Health System Research InstituteUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jan 2016 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Jan 2015 (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.
This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.
Detailed description
This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Grade I or II ventral hernia according to VHWG classification system
- Pre-operative informed consent is obtainable
Key exclusion criteria (9 listed)
- Not candidate for laparoscopic approach for repair of their hernia
- Determination in the operating room that biologic mesh is needed over permanent mesh
- Fascial defect less than 3 cm in greatest dimension
- Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed
- Grade III or IV ventral hernia according to VHWG system
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 |
|---|---|---|
| Symbotex™ Composite MeshRepair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh | Device | – |
Primary outcome
Hernia Recurrence
Time frame: One year
Quality of Life
Time frame: One year
Hernia associated pain and movement limitations pre-surgery compared to post-surgery
Time frame: One year
Reoperation Rate
Time frame: One year
Percutaneous Intervention Rate
Time frame: One year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
Time frame: One year
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 7 Feb 2019.
- Background: PubMed 20304452Ventral Hernia Working Group; Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, Kilbridge JF, Rosen M, Silverman RP, Vargo D. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010 Sep;148(3):544-58. doi: 10.1016/j.surg.2010.01.008. Epub 2010 Mar 20.
- Background: PubMed 14501505Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.
- BackgroundSymbotexTM clinging effect observed during the design validation conducted by Covidien in porcine model in May 2013- covidien internal memorandum 0901CR261a (July 2013)
- BackgroundMalangoni MA and Rosen MJ. Chapter 46: Hernias, Sabiston Textbook of Surgery 19th Edition. Elsevier; Philadelphia, PA. 2012: 1128-1135
- Background: PubMed 18387468Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.
- Background: PubMed 20404280Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18.
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.
Adrian Park, M.D. principal investigator
Anne Arundel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symbotex™ Composite Mesh in people with Grade I Ventral Hernia and Grade II Ventral Hernia, run by Anne Arundel Health System Research Institute at 1 site in United States.
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 3 inclusion and 9 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 7 Feb 2019. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Recurrence (time frame: One year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341430, which also lists 6 linked publications.
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 7 Feb 2019.