Ann Arbor, MINCT07277946Now EnrollingIRB Ready

Hernia Clinical Trial in Ann Arbor, MI

Access cutting-edge hernia treatment through this clinical trial at a research site in Ann Arbor. Study-provided care at no cost to qualified participants.

Sponsored by Tissium

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Expert Care in Ann Arbor

Access hernia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hernia treatment provided free

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Check if you qualify for this hernia clinical trial in Ann Arbor, MI

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Ann Arbor

    Convenient for MI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Ann Arbor site if eligible
  4. 4Begin participation

About This Hernia Study in Ann Arbor

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. This information will support understanding of ECLIPSIUM's potential clinical benefits in ventral hernia repair.

Sponsor: Tissium

Who Can Participate

Inclusion 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 intraoperatively).
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.

Exclusion Criteria

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 follow-up for products that were investigational, but have since become commercially available, are not considered investigational studies).
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT07277946) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hernia Treatment Options in Ann Arbor, MI

If you're searching for hernia treatment options in Ann Arbor, MI, this clinical trial (NCT07277946) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hernia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hernia clinical trials near you to find additional studies recruiting in your area.

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