Early Phase 1 Crohn's Disease and Colitis Trial, By Invitation NCT07636304 Sponsor: University of Gdansk Condition: Crohn's Disease and Colitis
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Early Phase 1 Crohn's Disease and Colitis Trial, By Invitation

NCT07636304
By Invitation Early Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • Adults aged 18 years or older.
  • People who have been diagnosed with inflammatory bowel disease (IBD), which includes Crohn's disease or ulcerative colitis.
  • People whose IBD is currently in remission, meaning their disease is not actively flaring, as confirmed by a doctor.
  • People who are able to give their formal agreement to take part in the study.
  • People who are able to follow the study procedures and use the stimulation device every day.
  • People who have no medical reasons preventing them from having an MRI scan.
  • People who have no medical reasons preventing them from using a non-invasive nerve stimulation device applied to the vagus nerve.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who are currently experiencing an active IBD flare or significant gut symptoms.
  • People who have a serious or life-threatening medical condition alongside their IBD, such as active cancer.
  • People who cannot have an MRI scan — for example, due to metal implants, a pacemaker, or severe claustrophobia.
  • People who cannot use the nerve stimulation device — for example, due to serious heart rhythm problems, a very slow heart rate, an implanted electronic medical device, a recent history of trigeminal neuralgia, or a previous surgery to cut the vagus nerve.
  • People who are currently pregnant.
  • People who have been diagnosed with a severe neurological or psychiatric condition.
  • People whose current medication affecting the brain or nervous system is being changed or adjusted.
  • People who are unable to follow the study procedures or complete the required assessments.

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 31 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

GP referral letter

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Trial details

Status
By Invitation
Phase
Early Phase 1
Sponsor
University of Gdansk
Registry
ClinicalTrials.gov
Start date
20 June 2026
Est. completion
15 December 2026

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation; Change in structural brain imaging measures following non-invasive vagus nerve stimulation

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: 31 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