Pancreatitis Trial, Recruiting NCT04033614 Sponsor: RWTH Aachen University Condition: Pancreatitis
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Pancreatitis Trial, Recruiting

NCT04033614
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had a procedure where your abdomen has been left open (called a "laparostoma") with a special dissolvable mesh in place, and doctors are planning a follow-up operation to check inside your abdomen.
  • You are an adult (of legal adult age in your country).
  • You (or your legal representative or guardian, if you are unable to make decisions yourself) have signed a consent form agreeing to take part.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You are extremely critically ill and doctors estimate you have less than 24 hours to live, even with the open abdomen procedure.
  • You have an unstable chest or known serious bone/skeletal problems that would prevent the study device (Fasciotens Abdomen) from being used safely on you.
  • You have open wounds or infections on the areas of your body where the study device would make contact with your skin.
  • You have been diagnosed with heart failure where your heart is pumping at a very low level (ejection fraction below 35%).
  • You have serious lung failure and doctors need to place you face-down for treatment within the next 24 hours.
  • You are currently living in a psychiatric hospital or care facility by order of a court or official authority.
  • You work for or are financially dependent on the lead doctor running this trial.
  • You are under the legal age of adulthood.
  • There are other medical or personal circumstances that the trial doctor feels would make using the study device unsuitable for you (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +49 241 80 89500

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
RWTH Aachen University
Registry
ClinicalTrials.gov
Start date
5 August 2019
Est. completion
1 May 2026

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Closure rate of the abdominal wall fascia

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov