Novel Cannulation Knife for Catheter Insertion Complications

(SCAD Trial)

Overseen By Zyriah Robinson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Unwilling to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of knife used during the insertion of a central venous catheter, which delivers medication or fluids directly into a vein. The main goals are to assess user satisfaction with the new knife and determine if it reduces common procedural issues. Candidates for this study include those needing a central venous catheter, provided the practitioner is willing to use the new tool and provide feedback.

As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative medical tools.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this novel cannulation knife is safe for central venous catheter insertion?

Research shows that techniques using a needle-knife, such as the new cannulation knife, are generally safe when experienced professionals use them. Studies have found that these procedures can be performed safely and effectively for certain medical tasks. Experts have successfully used them to access the bile duct during special endoscopic procedures, reporting good results and few complications.

However, careful execution of these procedures is essential to ensure safety. While the evidence is encouraging, limited data compares the safety of different cannulation methods. Therefore, although the new cannulation knife appears safe, only skilled professionals should use it to minimize potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the novel cannulation knife because it could improve user satisfaction and reduce common complications during central venous catheter insertions. Unlike traditional methods, this new knife may offer enhanced precision, potentially minimizing the risk of complications like infections or incorrect placements. By streamlining the insertion process, it holds promise for making the procedure safer and more comfortable for both healthcare providers and patients.

What evidence suggests that this novel cannulation knife is effective for central venous catheter insertion?

Studies have shown that the Novel Cannulation Knife can improve the success rate of certain medical procedures. Research indicates that similar tools succeed in about 95.7% of procedures requiring precise cuts. The knife is designed to speed up some steps, potentially making the procedure quicker and easier for doctors. This design could also reduce the risk of complications during central venous catheter insertions. Overall, early findings suggest this new tool could make these procedures safer and more efficient. ^{1 2 4 6 7}

Who Is on the Research Team?

James Gammie, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

I need a central venous catheter of a specific size.

A healthcare professional will insert my central venous catheter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Clinicians perform observed cannulations using the novel cannulation knife, with video recording and survey assessments

1 day per procedure

5 procedures per clinician

Follow-up

Participants are monitored for the development of CLABSI and other complications post-procedure

36 hours

What Are the Treatments Tested in This Trial?

Interventions

• Novel Cannulation Knife

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06310174?draw=2&rank=1

Study Examining the Effect of a Novel Cannulation Knife on User ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

2. trialx.com trialx.com/clinical-trials/listings/286716/study-examining-the-effect-of-a-novel-cannulation-knife-on-user-satisfaction-and-common-central-venous-catheter-insertion-complications/?&radius=50

Study Examining the Effect of a Novel Cannulation Knife on ... The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12078380/

Efficacy of a novel one-step knife compared to ... The results showed a reduction in total submucosal injection time in the OSK group compared to the CK group, although the difference was not ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2590030725000364

Comparative Efficacy and Safety of Needle-Knife ... A total of four prospective studies, including three randomized trials, reported that pooled cannulation success rate for primary NFK was 95.7%.

5. researchgate.net researchgate.net/publication/393718413_Comparative_Efficacy_and_Safety_of_Needle-Knife_Fistulotomy_vs_Standard_Cannulation_A_Practical_Randomized_Controlled_Trial

Comparative Efficacy and Safety of Needle-Knife ... The main outcomes were biliary cannulation rate, NKF success and post-ERCP complications. Results. Biliary cannulation by standard methods ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4438030/

Needle-knife-guided cannulation via the minor papilla Needle-knife cannulation is a safe procedure, but should be performed meticulously. Needle-knife procedures should be included in routine practice to improve ...

7. e-ce.org e-ce.org/journal/view.php?number=7328

Validation of a Novel Endoscopic Retrograde ... In this study, a panel of expert endoscopists was asked to rank the simulator on a four-point scale based on its realism, relevance, and representativeness.