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INL-001 (bupivacaine hydrochloride) implant for Postoperative Pain
Study Summary
This trial looks at the safety and how well the body tolerates a new pain medication given as an implant following various types of surgery.
- Postoperative Pain
- Ventral Hernia
- Tummy Tuck
- Hysterectomy
- Colectomy
- Breast Reduction Surgery
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
How can I sign up for the clinical trial?
"Eligibility criteria for this clinical trial includes being over 18 years old, having had a hysterectomy, and being below 75 years of age. Up to 100 individuals will be enrolled in the study."
Does this experiment have an age limit for participants?
"According to the inclusion criteria specified by the study, patients aged 18 to 75 are qualified applicants. Out of the 668 trials for people over 65 and 107 trials for those under 18, this is one of many medical studies."
Are new patients being taken in for this clinical trial?
"Yes, this information can be found on clinicaltrials.gov. The posting date was April 14th, 2021 and the most recent edit occurred on August 29th, 2022."
Are there any adverse effects to the INL-001 (bupivacaine hydrochloride) implant procedure?
"INL-001 (bupivacaine hydrochloride) implant is rated 3 out of 3 in terms of safety by our Power team. This Phase 3 trial status means that not only does this product have some data supporting efficacy, but also multiple rounds of data affirming its safety."
How many patients are included in this clinical trial?
"To carry out this research, 100 participants that meet the required inclusion criteria are needed. Innocoll, the sponsor of this trial, will be administering the study from locations such as Endeavor Clinical Trials in San Antonio and Baylor College of Medicine in Florence."
Are there different areas where this experiment is being conducted?
"8 clinical trial sites are currently recruiting patients for this study. If you choose to participate in the study, please select the site nearest to your location from the list below to minimize travel requirements.San AntonioFlorence Dayton 8 other locations"
What type of pain does INL-001 (bupivacaine hydrochloride) help to alleviate?
"The INL-001 (bupivacaine hydrochloride) implant is most often used to treat permphigus. However, it has also been effective in treating acute nonspecific tenosynovitis, lupus erythematosus cell, and general anesthesia."
What other research has been conducted using INL-001 (bupivacaine hydrochloride) implant?
"The INL-001 (bupivacaine hydrochloride) implant was first used in 2009 at Chang Gung Memorial Hospital. Since then, it has been employed in 728 completed studies with 124 of those trials still active. A considerable number of these active studies are based out of San Antonio, Alabama."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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