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Could a Sea-Shell pad replace the sandbag after heart procedures?

NCT ID NCT07771127

Disease control Sponsor: Uludag University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether a chitosan-based pad, made from crustacean shells, can control bleeding at the femoral puncture site better than the traditional sandbag after coronary angiography or intervention. It will compare bleeding, pain, comfort, and sleep quality in 480 adults undergoing these procedures. Participants will be randomly assigned to receive either the chitosan pad or a sandbag after the procedure. The goal is to see if the pad offers a more comfortable recovery with fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A chitosan-based hemostatic pad applied to the femoral puncture site after coronary angiography or intervention, compared with a conventional sandbag.
What this could lead to
If effective, the chitosan pad could reduce bleeding complications, pain, and discomfort while improving sleep and comfort for heart patients after femoral procedures.
What could go wrong
This is a single-center trial, and results may not apply broadly. The pad may not outperform the sandbag, and some people with shellfish allergies cannot use it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged 18 years and older scheduled for femoral coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) * Patients undergoing a single femoral arterial access procedure * Patients with sheath size typically 5-Fr, 6-Fr, or 7-Fr * Patients who are conscious, alert, and able to communicate * Patients who voluntarily agreed to participate in the study Exclusion Criteria: * Patients with known allergy to shellfish or chitosan Patients using antihistamines, psychotropic medications, or sleep medications Patients with systolic and/or diastolic blood pressure above 150/100 mmHg Patients with known bleeding disorders (e.g., hemophilia) or active bleeding Patients with severe renal or hepatic failure Pregnant or breastfeeding patients Patients with a history of malignancy

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary angiography Coronary artery disease Vascular access site complications

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bursa Uludag University Hospital

    RECRUITING

    Bursa, Nilüfer, 16059, Turkey (Türkiye)

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