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Hernia, Inguinal3DMSNCT07289802

Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair

An observational study of Hernia, Inguinal, run by Swissmed Hospital at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hernia, Inguinal
What is being tested?
3DMax MID Anatomical Mesh
Type of treatment
Medical device
How many people
300 participants
Where
1 sitePoland
Study dates
1 Feb 2026to 1 Apr 2027
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with primary unilateral or bilateral inguinal hernia undergoing elective laparoendoscopic (TAPP or TEP) repair with implantation of the 3DMax MID Anatomical Mesh in participating centers.

Who may be able to join

  • Age 18 years or older
  • Primary unilateral or bilateral inguinal hernia
  • Scheduled for elective laparoendoscopic inguinal hernia repair (TAPP or TEP)
  • Considered suitable for general anesthesia and laparoendoscopic approach by the treating surgeon
  • 3DMax MID Anatomical Mesh planned for use as part of routine clinical care
  • Ability and willingness to provide written informed consent

Who cannot join

  • Age below 18 years
  • Emergency surgery (e.g. incarcerated or strangulated hernia requiring urgent intervention)
  • Contaminated or potentially contaminated surgical field
  • Recurrent inguinal hernia in the same groin (previous repair with mesh or suture)
  • Concomitant procedures or clinical situations in which the surgeon decides that a different mesh concept or technique is required
  • Inability or unwillingness to comply with follow-up schedule (e.g. lack of telephone contact, severe cognitive impairment)

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Swissmed Hospital

    Gdansk, 80-280

Other trials in Poland

About this study

Official title: Safety and Efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in Laparoendoscopic Inguinal Hernia Repair: A Multicenter Prospective Observational Cohort Study

This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice.

The primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications.

All participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.

Read the detailed description

Laparoendoscopic techniques such as transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair are widely used for the treatment of inguinal hernia and are associated with faster recovery and lower rates of chronic pain compared with open repair in appropriately selected patients. Mesh reinforcement is a key component of these procedures. Three-dimensional, anatomically contoured meshes have been developed to improve conformability to the myopectineal orifice and to provide stable coverage of the inguinal region, potentially reducing the need for additional fixation and lowering the risk of chronic postoperative pain.

The 3DMax MID Anatomical Mesh (BD, USA) is a medium-weight, macroporous, pre-shaped polypropylene mesh designed specifically for inguinal hernia repair. Its three-dimensional configuration and recoil properties are intended to facilitate correct positioning and stable coverage of the inguinal anatomy during laparoendoscopic procedures.

This multicenter, prospective, observational cohort study will include consecutive adult patients undergoing elective TAPP or TEP inguinal hernia repair in participating centers, in whom the operating surgeon has decided to use the 3DMax MID Anatomical Mesh as part of routine practice. No randomization or control group is planned, and no interventions outside standard care will be performed.

Data will be collected from medical records and structured follow-up contacts (early postoperative check, approximately 30 days, 3 months and 12 months after surgery). The primary endpoint is hernia recurrence within 12 months. Secondary endpoints include postoperative pain, groin discomfort, foreign body sensation and early or late postoperative complications. Study data will be recorded in a standardized database and analyzed descriptively to characterize the safety profile and clinical performance of the 3DMax MID Anatomical Mesh in real-world practice.

Being tested
3DMax MID Anatomical Mesh
Keywords
Hernia, Mesh, Inguinal Hernia, Recurrence
Medical subject headings
Hernia, Inguinal, Hernia, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3DMax MID Anatomical MeshDevice

    Also called 3DMax MID

    Implantation of a pre-shaped, medium-weight, macroporous polypropylene anatomical mesh (3DMax MID Anatomical Mesh, BD, USA) during elective laparoendoscopic inguinal hernia repair (TAPP or TEP) as part of routine clinical practice. No additional experimental procedures beyond standard surgical care are planned.

Study groups in NCT07289802
Study groupRoleWhat they receive
3DMax MID TAPP/TEPAdult patients undergoing elective laparoendoscopic inguinal hernia repair (TAPP or TEP) with implantation of the 3DMax MID Anatomical Mesh (BD, USA) as part of routine clinical practice. No randomization or control group is used; all enrolled participants receive the same type of mesh according to the treating surgeon's standard technique.
Receives: Device: 3DMax MID Anatomical Mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inguinal hernia recurrence rate at 12 months

    Proportion of patients with clinically and/or imaging-confirmed inguinal hernia recurrence within 12 months after the index laparoendoscopic repair with 3DMax MID Anatomical Mesh.

    Measured: 12 months after index surgery

Secondary outcomes (4)

  1. Postoperative pain intensity (VAS 0-10)

    Postoperative pain intensity assessed using a 0-10 Visual Analog Scale (VAS) during early and late follow-up. Chronic pain will be defined as VAS ≥4 persisting beyond 3 months after surgery.

    Measured: 7-10 days, 30 days, 3 months and 12 months after surgery

  2. Early postoperative complications (≤30 days)

    Incidence of early postoperative complications within 30 days after surgery, including wound infection, hematoma, seroma, urinary retention, bleeding, and other mesh- or procedure-related adverse events.

    Measured: Up to 30 days after surgery

  3. Late postoperative complications (>30 days to 12 months)

    Incidence of late postoperative complications occurring between 30 days and 6 months after surgery, including chronic groin pain, mesh-related complications, and reoperations in the operated groin.

    Measured: From >30 days to 12 months after surgery

  4. Groin discomfort and foreign body sensation

    Patient-reported groin discomfort, stiffness and foreign body sensation in the operated region, assessed using standardized questions or Likert-type scales (0-10) during follow-up contacts.

    Measured: 7-10 days, 30 days, 3 months and 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start1 Feb 2026
  3. Primary completion1 Apr 2026
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07289802
Sponsor's protocol ID
3DMID-PL
Acronym
3DMS
Status last verified
Sep 2026
First submitted
4 Dec 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zamkowski M, S Mietanski M, Franczak P, Gorski D, Grabias J, Janik M, Krol A, Mitura K, Medras O, Nawacki L, Romanczuk M, Rymkiewicz P, Saluk S, Sroczynski P, Sulkowski L, Wieczorek D, Wlodarczyk M. MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized Controlled Trial-MEFISTO Trial. Ann Surg. 2025 Jun 1;281(6):921-927. doi: 10.1097/SLA.0000000000006669. Epub 2025 Feb 13.

    PubMed 39945075

  • Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.

    PubMed 36229552

  • Zamkowski M, Smietanski M. MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial-study protocol for a MEFI Trial. Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.

    PubMed 37670376

  • Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Putko M, Smietanski M. Mechanical stability of new-generation meshes for M3 inguinal hernia repair: experimental pressure chamber testing of SWING-Mesh and 3DMax MID Anatomical Mesh. Wideochir Inne Tech Maloinwazyjne. 2025 Oct 29;20(4):409-414. doi: 10.20452/wiitm.2025.17990. eCollection 2025 Dec 29.

    PubMed 41757330

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia, Inguinal, run by Swissmed Hospital at 1 site in Poland.

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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inguinal hernia recurrence rate at 12 months (time frame: 12 months after index surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07289802, which also lists 4 linked publications.

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 18 Sep 2026.

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