Study Stopped
Sponsor decision to end study.
Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
Presygen™
Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System
1 other identifier
observational
6
1 country
1
Brief Summary
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
January 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2019
CompletedJune 10, 2019
June 1, 2019
4 months
October 17, 2018
June 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.
Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue.
24 hours.
Secondary Outcomes (1)
Quantitative survey providing surgeon assessment of work station during procedure.
24 hours
Study Arms (1)
breast reconstruction surgery patients
Patients will be imaged with imaging device (Presygen™/si-1) during surgical procedure. Image surgical area. Surgical procedure will follow standard of care. No clinical decisions will be made on device readings. A surgeon will complete a survey regarding his assessment of the imaging device.
Interventions
Image surgical area
Eligibility Criteria
Patients undergoing breast reconstruction surgery and meet the inclusion and exclusion criteria.
You may qualify if:
- Candidate for surgical intervention with breast reconstruction as part of the surgical plan
- years of age or older;
- Able to understand and provide informed consent with HIPAA authorization.
- Able to read and understand in English.
You may not qualify if:
- Subjects who might need a legally-authorized representative
- Subjects who possess diminished mental capabilities
- Conditions that preclude imaging (excessive scarring, tattoos in surgical field, Fitzpatrick Scale VI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Englewood Hospital and Medical Cetner
Englewood, New Jersey, 07631, United States
Related Publications (2)
Pestana IA, Coan B, Erdmann D, Marcus J, Levin LS, Zenn MR. Early experience with fluorescent angiography in free-tissue transfer reconstruction. Plast Reconstr Surg. 2009 Apr;123(4):1239-1244. doi: 10.1097/PRS.0b013e31819e67c1.
PMID: 19337092RESULTColwell AS, Craft RO. Near-infrared spectroscopy in autologous breast reconstruction. Clin Plast Surg. 2011 Apr;38(2):301-7. doi: 10.1016/j.cps.2011.03.014.
PMID: 21620154RESULT
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2018
First Posted
October 23, 2018
Study Start
January 30, 2019
Primary Completion
June 5, 2019
Study Completion
June 5, 2019
Last Updated
June 10, 2019
Record last verified: 2019-06