This research study is evaluating an investigational product to assist with hernia repair in adults. You may be able to take part in this research study if you:
Are 18 to 80 years old
Have an abdominal hernia that requires open surgical repair
Have intact abdominal wall muscles as determined by a CT scan
The research study will involve 7 in-person visits over the course of 20 weeks and 6 follow-up phone calls every 4 months after the surgery. The research study will enroll approximately 200 participants.
You will first attend a screening visit to determine your eligibility for this research study. If you choose to proceed, you will complete a series of health assessments during the Day 1 visit and receive your assigned study medication. You will then attend a pre-surgery visit, which may be on the same day as your hernia repair surgery. There will be 3 additional study visits to assess your post-surgery health, followed by 6 phone calls, which will take place every 4 months after your surgery. If your responses during follow-up phone calls suggest that a hernia may have returned, the study doctor or staff may ask you to come back for an additional visit.
If eligible, study participation will last for up to 25 months, which includes 7 in-person visits and 6 phone calls.
The investigational product is an intramuscular (into the muscle) injection.
Do not discontinue any medication unless you are advised to do so by the study clinic staff or your primary care provider.
Eligible participants will receive all study-related medication (the investigational product or placebo) at no cost. Reimbursement may be provided for study-related travel expenses.
Clinical research studies are designed in specific ways, and one or more of the answers that you provided were outside of the guidelines for this research study. This does not mean you will not qualify for different research studies.
This research study is evaluating an investigational product to assist with hernia repair in adults. You may be able to take part in this research study if you:
Are 18 to 80 years old
Have an abdominal hernia that requires open surgical repair
Have intact abdominal wall muscles as determined by a CT scan
The research study will involve 7 in-person visits over the course of 20 weeks and 6 follow-up phone calls every 4 months after the surgery. The research study will enroll approximately 200 participants.
You will first attend a screening visit to determine your eligibility for this research study. If you choose to proceed, you will complete a series of health assessments during the Day 1 visit and receive your assigned study medication. You will then attend a pre-surgery visit, which may be on the same day as your hernia repair surgery. There will be 3 additional study visits to assess your post-surgery health, followed by 6 phone calls, which will take place every 4 months after your surgery. If your responses during follow-up phone calls suggest that a hernia may have returned, the study doctor or staff may ask you to come back for an additional visit.
If eligible, study participation will last for up to 25 months, which includes 7 in-person visits and 6 phone calls.
The investigational product is an intramuscular (into the muscle) injection.
Do not discontinue any medication unless you are advised to do so by the study clinic staff or your primary care provider.
Eligible participants will receive all study-related medication (the investigational product or placebo) at no cost. Reimbursement may be provided for study-related travel expenses.
Clinical research studies are designed in specific ways, and one or more of the answers that you provided were outside of the guidelines for this research study. This does not mean you will not qualify for different research studies.
