Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
NCT ID: NCT03937011
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
161 participants
OBSERVATIONAL
2019-12-13
2023-11-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stratafix Arm
The single study arm would comprise of two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure).
Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
1. Robotic Bariatric Sleeve gastrectomy
2. Robotic Hysterectomy with or without oophorectomy;
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
1. Robotic Bariatric Sleeve gastrectomy
2. Robotic Hysterectomy with or without oophorectomy;
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled
3. Subjects are ≥ 18 years of age
Exclusion:
1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints
4. Allergic to poly (p-dioxanon), IRGACARE®\* MP (triclosan) or D\&C Violet No. 2 colorant
5. Pregnant or lactating female subjects as confirmed prior to the procedure
6. Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu \& Morrow classification or gastric sleeve revision surgery
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ethicon, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Baptist Health South Florida
Miami, Florida, United States
Albany Medical
Albany, New York, United States
Mt. Sinai
New York, New York, United States
Lenox Hill hospital
New York, New York, United States
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , Germany
Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie
Kiel, , Germany
University of Naples
Naples, , Italy
University Pisa
Pisa, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ESC_2018_02
Identifier Type: -
Identifier Source: org_study_id