BridgeMD
New treatment option for Hernia, Ventral
Official title Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
ClinicalTrials.gov ID: NCT04779918
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or...
- 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...
- Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
- Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
You likely can't join if
- at Baseline:
- 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.
- Subject has recent history of drug or alcohol abuse (in last 3 years).
See the full eligibility criteria
- 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.
- Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
- Subject is able to complete Quality of Life (QoL) and pain questionnaires.
- Subject is at least 21 years old.
- Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.
- at Baseline:
- 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.
- Subject has recent history of drug or alcohol abuse (in last 3 years).
- Subject has an allergy to ovine-derived products.
- Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
- Subject has a strangulated hernia. Exclusion Criteria Intraoperative:
- Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
- Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Denver, Colorado, United States
- Destin, Florida, United States
- Fort Myers, Florida, United States
- Overland Park, Kansas, United States
- Louisville, Kentucky, United States
- Traverse City, Michigan, United States
- Roslyn, New York, United States
- Utica, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Denver, Colorado, United States; Destin, Florida, United States; Fort Myers, Florida, United States; Overland Park, Kansas, United States; Louisville, Kentucky, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.