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Tests treatment safety and results for Hernia
Official title AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
ClinicalTrials.gov ID: NCT07277946
What this study is testing
- What it's testing
- The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. The study will evaluate whether ECLIPSIUM, a bioresorbable polymer-based fixation device, is effective in reducing the risk of hernia recurrence when compared with bioresorbable tacks.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Patient is 22 years old or older.
- Patient is willing and able to provide a signed Patient Informed Consent Form.
- Patient has a single midline primary ventral, umbilical, or incisional hernia; a.Hernia Size is 1 -5 cm in diameter (to be confirmed...
- Patient is scheduled for a laparoscopic IPOM hernia repair.
- Hernia can be successfully repaired with a single polyester or polypropylene composite mesh with biodegradable coating with at least a 5 cm overlap...
You likely can't join if
- Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, comparator device, mesh, or other...
- Patient is taking systemic photosensitivity pharmaceutical products at time of informed consent.
- Patient has a BMI \> 40.
- Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.
- Patient's hernia is recurrent and/or the patient has a previous midline primary ventral, umbilical, or incisional hernia repair with mesh...
- Patient has a life expectancy less than 1 year, in the opinion of the Investigator.
See the full eligibility criteria
- Patient is 22 years old or older.
- Patient is willing and able to provide a signed Patient Informed Consent Form.
- Patient has a single midline primary ventral, umbilical, or incisional hernia; a.Hernia Size is 1 -5 cm in diameter (to be confirmed intraoperatively).
- Patient is scheduled for a laparoscopic IPOM hernia repair.
- Hernia can be successfully repaired with a single polyester or polypropylene composite mesh with biodegradable coating with at least a 5 cm overlap of the mesh on all sides of the defect (to be confirmed...
- Female patients must:
- Have a negative urine pregnancy test within 3 days before surgery and agree to consistently use an effective method of contraception through completion of study participation. OR
- Have reached menopause (no menses for 1 year). OR
- Have undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
- Patient is willing and able to follow the study instructions including completion of study procedures, assessments, and visits.
- Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, comparator device, mesh, or other surgical products (e.g., sutures).
- Patient is taking systemic photosensitivity pharmaceutical products at time of informed consent.
- Patient has a BMI \> 40.
- Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.
- Patient's hernia is recurrent and/or the patient has a previous midline primary ventral, umbilical, or incisional hernia repair with mesh implantation.
- Patient has a life expectancy less than 1 year, in the opinion of the Investigator.
- Patient is unwilling or unable to follow postoperative instructions.
- Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent.
- Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding.
- Patient has a diagnosis of Type 1 Diabetes Mellitus.
- Patient has uncontrolled Type 2 Diabetes Mellitus (HbA1C ≥ 7.0 within 3 months preceding study enrolment).
- Patient is currently participating in an investigational drug or device study that has not completed the primary outcome or that clinically interferes with this clinical study's outcome (Note: Studies requiring extended...
- Patient has more than one hernia defect (single hernia defect between 1-5 cm in diameter from outer edged to outer edge to be confirmed intraoperatively).
- Patient has areas of weakness, independent from the hernia to be treated, in the area covered by mesh or mesh-adjacent tissues (to be confirmed intraoperatively).
- Patient with a complex hernia, likely not eligible for laparoscopic repair, as determined by the Investigator (ex. small bowel resection; to be confirmed intraoperatively).
- Patient is scheduled for an additional surgery within 6 weeks after the index-procedure or has undergone surgery within 90 days before the index-procedure.
- Patient has severe chronic obstructive pulmonary disease.
- Patient has an ongoing infection (e.g. elevated temperature, elevated white blood count).
- In the opinion of the Investigator, the patient is not a suitable candidate for the clinical investigation.
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Gainesville, Florida, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Ann Arbor, Michigan, United States
- Omaha, Nebraska, United States
- Durham, North Carolina, United States
- Wilmington, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Knoxville, Tennessee, United States
- Newport News, Virginia, 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, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Gainesville, Florida, United States; Chicago, Illinois, United States; Lexington, Kentucky, United States; Ann Arbor, Michigan, United States; Omaha, Nebraska, United States and 6 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.