Ventral HerniaPPDSNCT03495154

Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair

A study testing Parietene DS Composite Mesh in people with Ventral Hernia, run by Medtronic - MITG at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventral Hernia
What is being tested?: Parietene DS Composite Mesh
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 6 sitesUnited States
Study dates: 21 Jun 2018to 6 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Preoperative Inclusion Criteria
Subject has provided informed consent
Subject is ≥18 years of age (at the time of consent)
Subject is undergoing elective ventral hernia repair (primary or incisional) with intraperitoneal mesh placement

Who cannot join

Preoperative Exclusion Criteria
BMI > 45 kg/m2
Subject is undergoing emergency surgery
Subject is pregnant or planning to become pregnant during study participation period
Subject is unable or unwilling to comply with the study requirements or follow-up schedule
Subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months

Show all 14Show fewer

The subject has participated in another investigational drug or device research study within 30 days of enrollment
Subject has a parastomal hernia
Intra-operative Exclusion Criteria
Subject's hernia repair is in a contaminated or infected site (CDC wound class 2-4) as assessed by the Investigator(s)
Subject is undergoing "bridging" repair technique with the mesh placed in an "inlay" position
Surgeon is unable to completely remove existing mesh from prior surgery
Surgeon overlays 2 meshes
Subject receives any mesh other than Parietene™ DS composite mesh

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Our Lady of the Lakes Regional Medical Center
Baton Rouge, Louisiana, 70808
University of Missouri - Columbia
Columbia, Missouri, 65201
The Ohio State University
Columbus, Ohio, 43210
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hernia Center of Excellence LLC
Newport News, Virginia, 23606

Other trials in United States

About this study

Official title: A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair

Read the detailed description

125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)

Conditions: Ventral Hernia
Being tested: Parietene DS Composite Mesh
Medical subject headings: Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Parietene DS Composite MeshDevice
All subjects enrolled will receive the Parietene DS Composite Mesh

Study groups in NCT03495154
Study group	Role	What they receive
Parietene DS Composite Mesh	Experimental	Patients treated with Parietene DS Composite Mesh Receives: Device: Parietene DS Composite Mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Measured: 12 months post surgery

Secondary outcomes (2)

Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair.
Measured: operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Measured: 1 month, 3 months, and 24 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 20186 Jul 2022

First posted11 Apr 2018
Study start21 Jun 2018
Primary completion21 Jul 2021
Study completion6 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ventral HerniaStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03495154
Sponsor's protocol ID: MDT17051PDS
Acronym: PPDS
Status last verified: Apr 2024
First submitted: 27 Mar 2018
Last updated: 23 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia

All Ventral Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair
ClinicalTrials.gov ID: NCT03495154
Acronym / sponsor ID: PPDS / MDT17051PDS
Conditions: Ventral Hernia
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 21 Jun 2018 (actual)
Primary completion: 21 Jul 2021 (actual)
Study completion: 6 Jul 2022 (actual)
First posted: 11 Apr 2018 (actual)
Results: Posted 17 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Parietene DS Composite Mesh	Experimental	Device: Parietene DS Composite MeshPatients treated with Parietene DS Composite Mesh

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Preoperative Inclusion Criteria

Key exclusion criteria (14 listed)

Preoperative Exclusion Criteria
Intra-operative Exclusion Criteria

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
Parietene DS Composite MeshAll subjects enrolled will receive the Parietene DS Composite Mesh	Device	Parietene DS Composite Mesh

Primary outcome

Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Time frame: 12 months post surgery

2 secondary outcomes

Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair.
Time frame: operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Time frame: 1 month, 3 months, and 24 months post-surgery

Results and safety

Results posted to the registry on 17 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parietene DS Composite Mesh	145	104

Primary outcome: Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair

Time frame: 12 months post surgery. Count of participants. Unit: Participants

Measure	Parietene DS Composite Mesh n = 120
Subjects With Hernia Recurrence at 12-Months	4
Subjects Without Hernia Recurrence at 12-Months	116

Parietene DS Composite Mesh: Percentage and confidence interval: 3.3 (95% CI 1.0 to 8.5)

Population analysed: Hernia recurrence rate at 12M changed from what was previously reported, 4 (3.5%) due to data imputed for hernia recurrence. It was assumed subjects who missed the 12M visit and had no recurrence at 24M also had no recurrence at 12M, as hernias cannot appear and then disappear over time without treatment. There were 5 subjects excluded from the primary endpoint analysis due to not completing the 12M/24M visits and therefore, unable to determine if a recurrence occurred in these subjects.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parietene DS Composite Mesh	29 of 125 (23.2%)	20 of 125 (16%)	2 of 125

Limitations and caveats (from the sponsor): There were no limitations or caveats in this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Ventral Hernia

Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia

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.

Sue Kim study director

Medtronic - Surgical Innovations

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Parietene DS Composite Mesh in people with Ventral Hernia, run by Medtronic - MITG at 6 sites 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 4 inclusion and 14 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair (time frame: 12 months post surgery). 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 NCT03495154.

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 23 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.