BridgeMD
TransNiDeG
EU CTIS ID: 2023-503349-71-00
What this study is testing
To assess the effect of transcutaneous administration of nicotine as compared to placebo on the development and severity of delayed gastric emptying (DGE) following pancreatoduodenectomy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- subject aged ≥ 18 years
- given written informed consent to participate in the trial
- planned for pancreatoduodenectomy (total pancreatectomy during surgery does not automatically exclude patients, right-sided pancreatectomy must be included)
- smokers must be willing to stop smoking for the duration of the IMP application (i.e. from Day 1 to Day 7)
You likely can't join if
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- Immediately after heart attack
- Severe cardiac arrhythmia
- Stroke that occurred shortly before
- Simultaneous participation in a clinical trial taking an investigational medicinal product, up to 30 days prior to last IMP intake in that clinical trial
- Current or planned pregnancy or nursing women
See the full eligibility criteria
- subject aged ≥ 18 years
- given written informed consent to participate in the trial
- planned for pancreatoduodenectomy (total pancreatectomy during surgery does not automatically exclude patients, right-sided pancreatectomy must be included)
- smokers must be willing to stop smoking for the duration of the IMP application (i.e. from Day 1 to Day 7)
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- Immediately after heart attack
- Severe cardiac arrhythmia
- Stroke that occurred shortly before
- Simultaneous participation in a clinical trial taking an investigational medicinal product, up to 30 days prior to last IMP intake in that clinical trial
- Current or planned pregnancy or nursing women
- Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep-tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- Distant organ metastases (which can be diagnosed after screening, e.g. during surgery; then no resection is performed according to guidelines; if oligometastatic disease is intentionally treated by resection, this does not automatically exclude patients))
- former gastrectomy
- liver fibrosis/cirrhosis
- Known history of hypersensitivity to nicotine or a compound of the investigational drug
- Systemic skin diseases
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.