ClinicalTrials.gg
RecruitingNCT07277946UNITEUpdated Oct 9, 2026

AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE

An interventional study of ECLIPSIUM® System and Resorbable tacks (AbsorbaTack/SorbaFix) in Hernia, sponsored by Tissium. Recruiting at 12 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Tissium · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 9, 2026Site recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hernia

Browse trials for

Keywords

  • Ventral Hernia Repair
  • Hernia
  • Hernia Repair
03

In context

Hernia

257 studies on the registry are indexed under Hernia; 37 are open to participants now.

This study's planned enrollment of 240 is above the median of 80 across 167 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Tissium is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient is 22 years old or older.
  2. Patient is willing and able to provide a signed Patient Form.
  3. Patient has a single midline primary ventral, umbilical, or incisional hernia;

    a.Hernia Size is 1 -5 cm in diameter (to be confirmed intraoperatively).

  4. Patient is scheduled for a laparoscopic IPOM hernia repair.
  5. 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).
  6. Female patients must:

    1. Have a negative urine pregnancy test within 3 days before surgery and agree to consistently use an effective method of through completion of study participation.

      OR

    2. Have reached menopause (no menses for 1 year). OR
    3. Have undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
  7. Patient is willing and able to follow the study instructions including completion of study procedures, assessments, and visits.

Exclusion criteria

Exclusion Criteria:

  1. Patient has a known or suspected to the constituent polymer of the device, comparator device, mesh, or other surgical products (e.g., sutures).
  2. Patient is taking systemic photosensitivity pharmaceutical products at time of .
  3. Patient has a > 40.
  4. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.
  5. Patient's hernia is recurrent and/or the patient has a previous midline primary ventral, umbilical, or incisional hernia repair with mesh implantation.
  6. Patient has a less than 1 year, in the opinion of the Investigator.
  7. Patient is unwilling or unable to follow postoperative instructions.
  8. Patient is taking systemic medications, systemic , or chemotherapy at the time of informed consent.
  9. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding.
  10. Patient has a diagnosis of Type 1 Diabetes Mellitus.
  11. Patient has uncontrolled Type 2 Diabetes Mellitus ( ≥ 7.0 within 3 months preceding study enrolment).
  12. 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).
  13. 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).
  14. 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).
  15. Patient with a complex hernia, likely not eligible for laparoscopic repair, as determined by the Investigator (ex. small bowel resection; to be confirmed intraoperatively).
  16. 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.
  17. Patient has severe .
  18. Patient has an ongoing infection (e.g. elevated temperature, elevated white blood count).
  19. In the opinion of the Investigator, the patient is not a suitable candidate for the clinical investigation.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    ECLIPSIUM System

    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.

    Device: ECLIPSIUM® System

  • Active comparator
    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)

Interventions

  • DeviceECLIPSIUM® System

    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.

  • DeviceResorbable 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.

06

What researchers measure

Primary outcomes

  1. Hernia Recurrence at 6 months

    Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery.

    Time frame: 6 months

  2. 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)

    Time frame: 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.

    Time frame: 12 months

07

Study locations

8 of 12 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.

Of 57 interventional studies with no phase under Hernia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's planned 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2025
First posted
Dec 11, 2025
StartActual
May 14, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
5 sites changed recruiting status (4 now recruiting, 1 now active, not recruiting)
Show 5 sites
  • University of Kentucky · Lexington, United StatesNot yet recruiting→Recruiting
  • University of Michigan Medical Center · Ann Arbor, United StatesNot yet recruiting→Recruiting
  • Creighton University · Omaha, United StatesNot yet recruiting→Recruiting
  • Duke University · Durham, United StatesNot yet recruiting→Recruiting
  • Tidewater Physicians Multi Specialty Group Hernia Center · Newport News, United StatesRecruiting→Active, not recruiting
Oct 9, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Tidewater Physicians Multi Specialty Group Hernia Center · Newport News, United StatesContact removed (no phone or email listed)Contact removed (no phone or email listed)
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    5 sites changed recruiting status (4 now recruiting, 1 now active, not recruiting)
    Show 5 sites
    • University of Kentucky · Lexington, United StatesNot yet recruiting→Recruiting
    • University of Michigan Medical Center · Ann Arbor, United StatesNot yet recruiting→Recruiting
    • Creighton University · Omaha, United StatesNot yet recruiting→Recruiting
    • Duke University · Durham, United StatesNot yet recruiting→Recruiting
    • Tidewater Physicians Multi Specialty Group Hernia Center · Newport News, United StatesRecruiting→Active, not recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Tidewater Physicians Multi Specialty Group Hernia Center · Newport News, United StatesContact removed (no phone or email listed)Contact removed (no phone or email listed)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07277946
Lead sponsor
Tissium
Responsible party
Sponsor
First posted
Dec 11, 2025
Start date
May 14, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 9, 2026

Study contacts

Nikia Trinward
Contact
ntrinward@tissium.com
1-857-408-0709
Michael Rosen
principal investigator · Northwestern University
William Hope
principal investigator · New Hanover Regional Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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