Health TrialsbyHealthPanel

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

ConditionsHernia, VentralHernia, Inguinal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorTela Bio Inc

About this trial

This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.

The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.

The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.

Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.

Disqualifiers

Subject has a BMI of > 40

Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria

Subject is female and is pregnant or plans to become pregnant during the course of the study.

Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.

Trial design

Design model

Single group

Treatments tested in this trial

  • OviTex Reinforced Tissue Matrix

    Device

    All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: OviTex Reinforced Tissue MatrixOther 1 intervention

Trial outcomes

Primary outcomes

1

Early surgical site occurrences or wound related events

Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site

Time frame
occurring within the first 3 months of the ventral or inguinal hernia repair
2

Early post-operative complications

Incidence of other early post-operative complications

Time frame
occurring within the first 3 months of the ventral or inguinal hernia repair.

Secondary outcomes

1

Late surgical site occurrences or wound related events

Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site

Time frame
occurring > 3 months after index surgery
2

Late post-operative complications

Incidence of other late post-operative complications

Time frame
occurring > 3 months after index surgery.
3

Patient Reported Outcomes

Patient Reported Outcomes (QoL and pain assessments)

Time frame
Assessed at day 30, day 90, 12 months, and 24 months post-op
4

Hernia Recurrence

True hernia recurrence at the site of surgery

Time frame
at post-operative day 90 and months 12 and 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tela Bio Inc

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov
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