For Healthcare Professionals

A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair

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About the study

The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Subject is between 18 and 80 years of age.
  2. Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
  3. Ventral hernia repair that will require mesh placement

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Subject is contraindicated for general anesthesia or surgery.
  2. Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
  3. Subject has a recurrent hernia.
  4. Subject who will have an emergent hernia repair.
  5. Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
  6. Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
  7. Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
  8. Subject with a history of MRSA infection.
  9. Subject with HbA1c level > 8.5%.
  10. Use of Exparel during the surgical procedure.
  11. Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
  12. Current nicotine use (including vaping) within the past 30 days.
  13. Subject has a known bleeding or clotting disorder.
  14. Pregnant or suspected pregnancy.
  15. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent.
  16. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
  17. Subject is currently participating in another interventional or investigational research study.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 682-552-6131Email iconEmail Study Center

Study Details


Contition

Ventral Hernia

Age

18 - 80

Participants Needed

200

Est. Completion Date

Dec 31, 2025

Treatment Type

OBSERVATIONAL


Sponsor

Intuitive Surgical

ClinicalTrials.gov NCT Identifier

NCT04855227

Study Number

Aspire

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