- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04165525
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study (CHEST)
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology (CHEST) Study
Studieoversigt
Detaljeret beskrivelse
The objective of this study is to evaluate device efficacy between the HelixAR Electrosurgical Generator (HEG) and Conventional Electrosurgical Coagulation (CEC) Systems for cutting and/or coagulation of tissue during mastectomy procedures and reconstructive surgery.
The study is designed and powered to demonstrate the superiority of the HEG to CEC in relation to a key efficacy measure: post-mastectomy procedure time to hemostasis. Secondary outcome measures include: infection, drain duration, total drain output, blood loss, and device related adverse events. These outcomes will be evaluated in a controlled population undergoing mastectomy procedures.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: cynthia C Harris, BS
- Telefonnummer: 8326776747
- E-mail: cindy@clinregconsult.com
Undersøgelse Kontakt Backup
- Navn: Michael A Daniel, BS, MS,MB
- Telefonnummer: 4154070223
- E-mail: madaniel@clinregconsult.com
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Baylor St. Luke's Medical Center
-
Kontakt:
- Brian Menegaz
- E-mail: Brian.Menegaz@bcm.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for a unilateral or bilateral mastectomy and reconstruction. All subjects enrolled and consented will undergo mastectomy with a breast reconstruction procedure, if it is in the subject's best interest.
Exclusion Criteria:
- Advanced refusal of blood transfusion, if necessary;
- Active systemic or cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- Uncontrolled diabetes mellitus
- Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count < 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
- Severe co-existing morbidities having a life expectancy of less than 30 days;
- Currently involved in any other investigational clinical studies that could influence outcomes;
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- Renal insufficiency (serum creatinine of > 2.5 mg/dl);
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
- Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: HelixAR Electrosurgical Generator (HEG)
Argon gas and high frequency electrical current ablation device
|
comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.
|
Aktiv komparator: Conventional Electrosurgical Coagulation (CEC) Systems
Standard Bovie electrosugical device without argon gas
|
comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The time measured from post-mastectomy to hemostasis for each operated breast.
Tidsramme: Inter-operative
|
time
|
Inter-operative
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
drain output
Tidsramme: up to two weeks post surgery
|
ml
|
up to two weeks post surgery
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
infection rate
Tidsramme: two months from procedure
|
comparison between arms
|
two months from procedure
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Stacey A Carter, MD, Baylor St. Luke's Medical Center
Publikationer og nyttige links
Generelle publikationer
- McGuire A, Brown JA, Malone C, McLaughlin R, Kerin MJ. Effects of age on the detection and management of breast cancer. Cancers (Basel). 2015 May 22;7(2):908-29. doi: 10.3390/cancers7020815.
- Steiner, C.A.; Weiss, A.J.; Barrett, M.L.; Fingar, K.R.; Davis, P.H (2016).
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DD01112019
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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