HerniaUNITENCT07277946
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
A study testing ECLIPSIUM® System and Resorbable tacks (AbsorbaTack/SorbaFix) in people with Hernia, run by Tissium at 12 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- ECLIPSIUM® System and Resorbable tacks (AbsorbaTack/SorbaFix)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesUnited States
- Study dates
- 14 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 11 recruiting
- Recruiting
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Wajid Khan, kwajid@med.umich.edu
Jnney Shao
- Recruiting
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611
Harika Reddy, harika.reddy@northwestern.edu
Michael Rosen
- Not yet recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Christine Moegling, drabekc@ccf.org
Luciano Tastaldi
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Kayla Diaz, kayla.diaz@osumc.edu
Ben Poulose
- Recruiting
Duke University
Durham, North Carolina, 27704
Jin Yoo
Jin Yoo
- Not yet recruiting
University of Florida Health
Gainesville, Florida, 32610
Gerik Tushoski, gerik.tushoski@surgery.ufl.edu
Mazen Al-Mansour
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Kaela Blake
Kaela Blake
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Sydney Cloyd, sydney.cloyd@uky.edu
Scott Roth
- Not yet recruiting
VA Loma Linda
Loma Linda, California, 92357
Archana Ramaswamy
Archana Ramaswamy
- Active, not recruiting
Tidewater Physicians Multi Specialty Group Hernia Center
Newport News, Virginia, 23606
- Recruiting
Creighton University
Omaha, Nebraska, 68178
Andy Yang
Andy Yang
- Recruiting
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28403
Reagan Peace, reagan.peace@novanthealth.org
Samantha Straka, samanthap.straka@novanthealth.org
About this study
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.
Read the detailed description
A prospective, multi-center, randomized, active control, single-blind non- inferiority study designed to evaluate the safety and effectiveness of the ECLIPSIUM® System versus bioresorbable tacks in mesh fixation in patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures.
- Conditions
- Hernia
- Being tested
- ECLIPSIUM® System, Resorbable tacks (AbsorbaTack/SorbaFix)
- Keywords
- Ventral Hernia Repair, Hernia, Hernia Repair
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECLIPSIUM® SystemDevice
The ECLIPSIUM® System functions by applying a biodegradable, implantable polymer coating to the prosthetic material under guidance of a template to ensure appropriate application, followed by in situ photo-activation using the TISSIUM curing light to secure the mesh to the abdominal wall.
Resorbable tacks (AbsorbaTack/SorbaFix)Device
Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function.
| Study group | Role | What they receive |
|---|---|---|
| ECLIPSIUM System | Experimental | The ECLIPSIUM System is intended for non-penetrating connection and fastening of prosthetic materials, such as composite meshes, to internal soft tissue during minimally invasive hernia repair procedures by coating the prosthetic material with the biodegradable implantable polymer and photoactivating it in situ with a TISSIUM curing light. Receives: Device: ECLIPSIUM® System |
| Resorbable tacks (AbsorbaTack/SorbaFix) | Active comparator | Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function. Receives: Device: Resorbable tacks (AbsorbaTack/SorbaFix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence at 6 months
Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery.
Measured: 6 months
Cumulative Incidence of Complications
Safety of the ECLIPSIUM System will be assessed by collecting and analyzing the cumulative incidence of complications (CIC) related to the ECLIPSIUM System including the following complications:
- Infection
- Chronic pain (defined as moderate or greater pain lasting more than 3 months) not otherwise specified
- Impaired/delayed healing at the surgical site (i.e. hernia repair site; example dehiscence)
- Allergic reaction/hypersensitivity reaction to the constituent polymer of the investigational device
- Serious Adverse Device Effect (SADEs)
Measured: 12 months
Secondary outcomes (1)
Hernia Recurrence at 12 months
The secondary efficacy outcome of this study is to demonstrate the rate of hernia recurrence of the ECLIPSIUM System is non-inferior compared to resorbable tacks at 12 months post-surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start14 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization, single-blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tissium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Rosen, Principal investigator, Northwestern UniversityWilliam Hope, Principal investigator, New Hanover Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277946
- Sponsor's protocol ID
- PF00006-CLPR-003
- Acronym
- UNITE
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- UNITE / PF00006-CLPR-003
- Conditions
- Hernia
- Keywords
- Ventral Hernia Repair, Hernia, Hernia Repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- TissiumIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective, multi-center, randomized, active control, single-blind non- inferiority study designed to evaluate the safety and effectiveness of the ECLIPSIUM® System versus bioresorbable tacks in mesh fixation in patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1:1 randomization, single-blinded
| Arm | Type | Receives |
|---|---|---|
| ECLIPSIUM System | Experimental | Device: ECLIPSIUM® SystemThe ECLIPSIUM System is intended for non-penetrating connection and fastening of prosthetic materials, such as composite meshes, to internal soft tissue during minimally invasive hernia repair procedures by coating the prosthetic material with the biodegradable implantable polymer and photoactivating it in situ with a TISSIUM curing light. |
| Resorbable tacks (AbsorbaTack/SorbaFix) | Active comparator | Device: Resorbable tacks (AbsorbaTack/SorbaFix)Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECLIPSIUM® SystemThe ECLIPSIUM® System functions by applying a biodegradable, implantable polymer coating to the prosthetic material under guidance of a template to ensure appropriate application, followed by in situ photo-activation using the TISSIUM curing light to secure the mesh to the abdominal wall. | Device | ECLIPSIUM System |
| Resorbable tacks (AbsorbaTack/SorbaFix)Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function. | Device | Resorbable tacks (AbsorbaTack/SorbaFix) |
Primary outcome
Hernia Recurrence at 6 months
Time frame: 6 months
Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery.
Cumulative Incidence of Complications
Time frame: 12 months
Safety of the ECLIPSIUM System will be assessed by collecting and analyzing the cumulative incidence of complications (CIC) related to the ECLIPSIUM System including the following complications: * Infection * Chronic pain (defined as moderate or greater pain lasting more than 3 months) not otherwise specified * Impaired/delayed healing at the surgical site (i.e. hernia repair site; example dehiscence) * Allergic reaction/hypersensitivity reaction to the constituent polymer of the investigational device * Serious Adverse Device Effect (SADEs)
1 secondary outcome
Hernia Recurrence at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Rosen principal investigator
Northwestern University
William Hope principal investigator
New Hanover Regional Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECLIPSIUM® System and Resorbable tacks (AbsorbaTack/SorbaFix) in people with Hernia, run by Tissium at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikia Trinward (1-857-408-0709, ntrinward@tissium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia Recurrence at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.