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Single arm study for Breast Cancer (iPIVAP Trial)

N/A

Waitlist Available

Led By Deborah H Allen, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years.

Awards & highlights

iPIVAP Trial Summary

This trial will study staff attitudes towards a new practice of inserting IVs on the same side as lymph node removal.

Eligible Conditions

Breast Cancer
Lung Cancer
Melanoma
Lymphedema

iPIVAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identify facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection.

Secondary outcome measures

Lymphedema symptoms; patient reported outcomes (PRO)

Lymphedema

Study participation acceptance

+1 more

iPIVAP Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm studyExperimental Treatment1 Intervention

Patients with a history of axillary surgical lymph node procedures (SLNP) presenting for routine radiographic scan will complete baseline measures: bilateral volumetric measurements and self-reported symptoms. Patients will undergo SOC contralateral arm intravenous access attempt. After one failed attempt, ipsilateral intravenous access instead of pedal or neck access will be offered per research protocol. Nursing documentation will reflect the failed venipuncture and categorize a reason for the failed attempt.

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,066 Total Patients Enrolled

53 Trials studying Breast Cancer

9,948 Patients Enrolled for Breast Cancer

Deborah H Allen, PhDPrincipal InvestigatorDuke Health

1 Previous Clinical Trials

25 Total Patients Enrolled

Frequently Asked Questions

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

Are there any open slots left in this clinical trial?

"Confirmed, as indicated by clinicaltrials.gov this investigation is actively recruiting participants. It was first posted on September 20th 2021 and the information has been updated for October 7th 2022."

Answered by AI

How many subjects are taking part in this clinical experiment?

"Affirmative. According to the details on clinicaltrials.gov, this treatment program is actively seeking participants since its inception in September 2021 and last update in October 2022. At present, 50 patients are needed across one centre of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study)

2021. "Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570722.