ASHI INTECC Astato XS 20 for Lacerations

1
Effectiveness
1
Safety
University of Washington Division of Cardiology, Seattle, WA
Lacerations+1 More
ASHI INTECC Astato XS 20 - Device
Eligibility
18+
All Sexes
Eligible conditions
Lacerations

Study Summary

This study is evaluating whether a new technique for mitral valve replacement is safe and effective.

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Eligible Conditions

  • Lacerations
  • Mitral Valve Failure

Treatment Effectiveness

Study Objectives

This trial is evaluating whether ASHI INTECC Astato XS 20 will improve 2 primary outcomes in patients with Lacerations. Measurement will happen over the course of Exit from the Cardiac Catheterization Laboratory.

Exit from the Cardiac Catheterization Laboratory
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure

Trial Safety

Trial Design

2 Treatment Groups

Control
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. ASHI INTECC Astato XS 20 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical OptionThe LAMPOON procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: exit from the cardiac catheterization laboratory
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly exit from the cardiac catheterization laboratory for reporting.

Closest Location

University of Washington Division of Cardiology - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient's risk of LVOT obstruction or transcatheter heart valve dysfunction is high, due to the long and redundant anterior mitral valve leaflet. show original
The text discusses the selection process for a study show original
can possess up to 1 ounce of marijuana Adults aged 21 years or older in the US are legally allowed to possess up to 1 ounce of marijuana. show original
The text discusses a problem that can occur after a mitral annuloplasty repair or related to mitral annular calcification show original
The patient has an unacceptably high or prohibitive risk for surgical mitral valve replacement and is indicated for transcatheter mitral valve replacement (TMVR) as determined by the multidisciplinary institutional heart team, including at least one cardiovascular surgeon who has examined the patient. show original
Based on the results of the baseline CT and echocardiogram, the patient is anatomically eligible for LAMPOON. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can lacerations be cured?

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The probability of healing is determined by the degree of contamination of the laceration wound with normal skin but the healing does depend on the time of laceration healing. The degree of wound infection plays no part in its healing. There is no cure for a laceration, only a way to stop the bleeding and the laceration wound is healed.

Unverified Answer

How many people get lacerations a year in the United States?

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About 100,000 people get a laceration every year. Most lacerations result from motor vehicle accidents; however, fall-related penetrating injuries, assaults, and sports injuries are also common causes of lacerations. Preventive measures (such as limiting alcohol and driving), limiting use of protective gear, wound care, and prevention of motor vehicle collisions are paramount in reducing the morbidity of injuries with complications, including lacerations.

Unverified Answer

What are common treatments for lacerations?

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Lacerations are frequently cleaned with wash cloths, then bandaged and left to heal without treatment. Occasionally, the wound is sealed with sutures, then the wound is left to heal by secondary intention. There is no good evidence for any other treatment than clean wounds with wash cloths. This question is commonly discussed among wound practitioners and is raised at the time of initial care for most wounds of moderate-to-heavy severity.

Unverified Answer

What is lacerations?

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Lacerations are a serious injury of the skin/subcutaneous tissue that can occur during surgical operations, recreational activities, and medical care. Severe lacerations can be fatal or result in significant disability.\n

Unverified Answer

What are the signs of lacerations?

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Lacerations of the scalp have a number of signs and symptoms including loss of consciousness, headache, visual disturbance, tearing and nasal discharge. The loss of consciousness is the hallmark sign of laceration of the scalp when a patient is in a hospital. It is important that the patient is evaluated to look for any of the symptoms or signs listed above. These symptoms can potentially indicate a more serious and life-threatening condition such as skull fracture.

Unverified Answer

What causes lacerations?

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Contact sports, head trauma, and domestic abuse are potential causes of lacerations in children. Children should have their sport and activities supervised by a medical professional, and they should be instructed to be clear, honest, forthcoming, and avoid trauma to the torso and the head.

Unverified Answer

What are the common side effects of ashi intecc astato xs 20?

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Results from a recent clinical trial demonstrates that ashi intecc astato xs 20 is easy to administer, well tolerated, and has an excellent safety profile. Clinicaltrials.gov identification: NCT00581235.

Unverified Answer

How serious can lacerations be?

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Based on this survey, the majority of patients are treated aggressively and are discharged from the emergency department without a requirement for further care. These trends may not be universal, and further study is necessary. The major limitation of this study was the retrospective design.

Unverified Answer

What is ashi intecc astato xs 20?

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In a recent study, findings was the first to describe the results of ashi intecco as a treatment for acute pancreatitis secondary to severe alcoholic pancreatitis. It was successful in alleviating signs of acute pancreatitis and in reducing the severity of abdominal pain.

Unverified Answer

Has ashi intecc astato xs 20 proven to be more effective than a placebo?

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This proof of concept study of Ashi Intecc Astato X has demonstrated that topical application of ashi is effective in reducing the pain of a laceration wound, and as such is a potential analgesic and wound dressing for laceration wounds of both soft and hard tissue.

Unverified Answer

What is the primary cause of lacerations?

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The number of blunt injuries to the head are associated with a higher frequency of lacerations, and there was a significantly lower frequency of penetrating injuries, which are most likely to cause lacerations and also increase the death rate of those sustaining injuries associated with blunt trauma. Recent findings, penetrating trauma was the primary cause of head injuries with a higher percentage of severe head injuries in the group with blunt trauma. In the blunt trauma group, there was a much higher frequency of blunt force lacerations, but death was not directly associated with blunt trauma injuries alone. Blunt trauma alone has potential for head injuries that are fatal, but it is not the primary cause of head injuries.

Unverified Answer

Have there been any new discoveries for treating lacerations?

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Only 10 % of the lacerations were surgically repaired, despite the fact that a large number of these injuries resulted in loss of life or disability. This would mean that the rest of the patients must cope with their injuries in other ways. In order to treat such patients, doctors must consider the seriousness of the injury, and the chances of long-term disability, whether patients are able to afford surgery, the degree of social deprivation, the likelihood of recovery.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Lacerations by sharing your contact details with the study coordinator.