Hemparacentes för kvinnor med cancerrelaterad malign ascites (Paracentes) (Paracentesis)
En pilotstudie av hemparacentes för kvinnor med cancerrelaterad malign ascites: En decentraliserad interventionsbehandlingsstudie (Paracentes)
The goal of this study is to evaluate the change in symptoms for cancer-related malignant ascites who complete an at-home paracentesis procedure.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Susan Sharry
- Telefonnummer: 801-585-3453
- E-post: susan.sharry@hci.utah.edu
Studieorter
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-
Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- Rekrytering
- Huntsman Cancer Institute at the University of Utah
-
Kontakt:
- Susan Sharry
- Telefonnummer: 801-585-3453
- E-post: Susan.sharry@hci.utah.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Participants aged ≥ 18 years
- Able to speak and understand English.
- Has completed an initial clinic-based paracentesis procedure.
- Confirmed diagnosis of cancer.
- Symptoms related to ascites requiring procedure in the opinion of the investigator.
- Eligible to receive an ultrasound-guided paracentesis procedure at home in the opinion of the investigator.
- If applicable, participant is able to safely hold anticoagulant therapy per institutional standards prior to the procedure in the opinion of the investigator.
- For participants of child-bearing potential, participant is following standard of care guidelines for contraception.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
- Rapidly deteriorating condition or suspected bowel obstruction.
- Large ventral hernias or prior complications from paracentesis.
- Need for concurrent procedures requiring hospital resources.
- Known lack of safe environment or inability to obtain sterile conditions at home.
- Any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the procedure or clinical study due to safety concerns or compliance with clinical study procedures. For example,
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: At-home Paracentesis
Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility. |
Paracentesis is a bedside procedure to obtain ascitic fluid from the peritoneum through needle aspiration, performed for both diagnostic and therapeutic purposes. The procedure involves needle insertion into the peritoneal cavity to remove fluid for analysis or to relieve symptoms from tense ascites. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
Tidsram: 3 months
|
To evaluate the change in symptoms in patients who complete at-home paracentesis. The AIM survey consists of 3 questions from 0 (No Symptoms) to 5 (Very Severe). A lower score is better. At the end of the study, all the results will be added together for the TSS. A lower score is preferred to show a positive outcome. |
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Tidsram: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).
Tidsram: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Tidsram: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Tidsram: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention.
Tidsram: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion.
Tidsram: 3 months
|
To assess the rate of procedure-related complications after at-home paracentesis. |
3 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Anna Beck, MD, Huntsman Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HCI198711
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