MastectomyNCT03757793
Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
An observational study of Mastectomy and Breast Reconstruction, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Breast Reconstruction, Flap Ischemia
- What is being tested?
- FORE-SIGHT ELITE monitor
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Sep 2018to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women, over 18 years, undergoing unilateral or bilateral DIEP flap procedure
Who may be able to join
- scheduled for elective unilateral or bilateral breast reconstruction via DIEP flap procedure.
Who cannot join
- refusal of written informed consent
- redo-surgery
- known history of allergy to adhesives
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s).
Read the detailed description
After a complex resection for breast cancer (e.g. mastectomy), a microvascular flap reconstruction can be used to fill up the tissue defects. A deep inferior epigastric artery perforator (DIEP)-flap is one of the most used microvascular flap reconstructions. Skin and fat from the abdomen are used to reconstruct a new breast.The success ratio of this type of surgery is high, more than 95%. Nevertheless, free flap failure can have disastrous consequences.The flap can be injured by surgical factors such as vascular complications.This is one of the major concerns and it usually occurs in the first hours after surgery. The success rate of the free flap depends on the continuous arterial inflow and the venous outflow through the new microvascular anastomoses. Thrombosis, kinking or external compression on the micro- and macrovascular blood vessels can cause necrosis of the flap. It is essential to recognize these complications as fast as possible to maximize the potential for flap salvage. Physical examination is still the gold standard for flap monitoring. However this monitoring is subjective, labor intensive and requires experience. Because of these disadvantages, a more objective method is desirable. In this suggested project, the flap will be monitored with FORE-SIGHT ELITE monitor( CAS Medical Systems incorporated) during the first 72 hours postoperatively. In this period most complications occur. The FORE-SIGHT ELITE Absolute Tissue Oximeter is a non-invasive device that measures absolute tissue oxygen saturation. It operates on the principle that blood contains hemoglobin in two primary forms, oxygenated hemoglobin (HbO2 ) and de-oxygenated hemoglobin (Hb), which absorb near-infrared light in different, measurable ways.The FORE-SIGHT ELITE incorporates CAS Medical Systems exclusive technology to project harmless near-infrared light in five precise wavelengths (690, 730, 770, 810 and 870 nanometer). An algorithm analyzes the reflected wavelengths. The algorithm is specially designed for the tissue with attention to unique characteristics of the tissue. Reflected light is captured by detectors positioned on the sensor for optimal signal collection. After analyzing the reflected light, the FORE-SIGHT ELITE displays the tissue oxygen saturation level on the monitor as an absolute number and provides a graphical representation of historical values.The FORE-SIGHT ELITE has been validated to determine cerebral tissue oxygen saturation amongst other in brain surgery. Tissue oxygen saturation (StO2) levels are determined by the ratio of oxygenated hemoglobin to total hemoglobin at the microvascular level (arterioles, venules, and capillaries) in the region to which the sensor is applied. This technique is called Near Infrared Spectroscopy (NIRS).Validated use of NIRS would be a major advantage to detect ischaemia in DIEP flaps. In the study pediatric sensor size is used to ensure proper depth of light penetration in a limited operating zone. By application of small neonatal sensors ( Foresight®-sensors (CASMED, Branford, CT, USA), on unilateral or bilateral DIEP flaps,light penetrates at 1.25cm depth.This reflects the perfusion and the oxygen consumption in the free flap.
A control pediatric sensor is placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects the normal tissue oxygenation of the patient. NIRS uses this technology for the detection of ischemia and hypoxia. It is a real-time, continuous, non-invasive method.
- Conditions
- Mastectomy, Breast Reconstruction, Flap Ischemia
- Being tested
- FORE-SIGHT ELITE monitor
- Keywords
- Near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORE-SIGHT ELITE monitorDevice
At end of surgery, one sensor of the FORE-SIGHT Elite monitor is placed on the DIEP flap or two sensors in case of bilateral DIEP flaps for monitoring perfusion and oxygen consumption in the free flap. A control sensor of the FORE-SIGHT Elite monitor placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects normal tissue oxygenation. Data obtained from the FORE-SIGHT Elite monitor will be compared to data obtained from physical examination, which is standard of care for flap monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Reliability of NIRS in DIEP flap surgery | In patients who underwent DIEP flap surgery, monitoring of postoperative tissue oxygen saturation of the flap by use of the FORE-SIGHT Elite monitor will be compared to standard of care physical examination. Receives: Device: FORE-SIGHT ELITE monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of ischaemia after DIEP flap surgery by use of NIRS
The aim of the study is to determine whether near infrared spectrometry(NIRS) would be a validated tool to detect early microvascular complications. A decrease of 10% of the Sct O2 taken at the DIEP flap(s) compared to Sct O2 of the abdomen will be considered as possible risk of ischaemia.
Measured: first 72 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start28 Sep 2018
- Primary completion22 May 2025
- Study completion1 Sep 2025
Why it stopped: It is practically not feasible to maintain the electrodes in place for 72 hours.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joke De Wachter, University Hospital, Antwerp
- Investigators
- Vera Saldien, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757793
- Sponsor's protocol ID
- 18/12/173
- Status last verified
- Sep 2025
- First submitted
- 27 Nov 2018
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03757793
- Acronym / sponsor ID
- 18/12/173
- Conditions
- Mastectomy, Breast Reconstruction, Flap Ischemia
- Keywords
- Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: It is practically not feasible to maintain the electrodes in place for 72 hours.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s).
Detailed description
After a complex resection for breast cancer (e.g. mastectomy), a microvascular flap reconstruction can be used to fill up the tissue defects. A deep inferior epigastric artery perforator (DIEP)-flap is one of the most used microvascular flap reconstructions. Skin and fat from the abdomen are used to reconstruct a new breast.The success ratio of this type of surgery is high, more than 95%. Nevertheless, free flap failure can have disastrous consequences.The flap can be injured by surgical factors such as vascular complications.This is one of the major concerns and it usually occurs in the first hours after surgery. The success rate of the free flap depends on the continuous arterial inflow and the venous outflow through the new microvascular anastomoses. Thrombosis, kinking or external compression on the micro- and macrovascular blood vessels can cause necrosis of the flap. It is essential to recognize these complications as fast as possible to maximize the potential for flap salvage. Physical examination is still the gold standard for flap monitoring. However this monitoring is subjective, labor intensive and requires experience. Because of these disadvantages, a more objective method is desirable. In this suggested project, the flap will be monitored with FORE-SIGHT ELITE monitor( CAS Medical Systems incorporated) during the first 72 hours postoperatively. In this period most complications occur. The FORE-SIGHT ELITE Absolute Tissue Oximeter is a non-invasive device that measures absolute tissue oxygen saturation. It operates on the principle that blood contains hemoglobin in two primary forms, oxygenated hemoglobin (HbO2 ) and de-oxygenated hemoglobin (Hb), which absorb near-infrared light in different, measurable ways.The FORE-SIGHT ELITE incorporates CAS Medical Systems exclusive technology to project harmless near-infrared light in five precise wavelengths (690, 730, 770, 810 and 870 nanometer). An algorithm analyzes the reflected wavelengths. The algorithm is specially designed for the tissue with attention to unique characteristics of the tissue. Reflected light is captured by detectors positioned on the sensor for optimal signal collection. After analyzing the reflected light, the FORE-SIGHT ELITE displays the tissue oxygen saturation level on the monitor as an absolute number and provides a graphical representation of historical values.The FORE-SIGHT ELITE has been validated to determine cerebral tissue oxygen saturation amongst other in brain surgery. Tissue oxygen saturation (StO2) levels are determined by the ratio of oxygenated hemoglobin to total hemoglobin at the microvascular level (arterioles, venules, and capillaries) in the region to which the sensor is applied. This technique is called Near Infrared Spectroscopy (NIRS).Validated use of NIRS would be a major advantage to detect ischaemia in DIEP flaps. In the study pediatric sensor size is used to ensure proper depth of light penetration in a limited operating zone. By application of small neonatal sensors ( Foresight®-sensors (CASMED, Branford, CT, USA), on unilateral or bilateral DIEP flaps,light penetrates at 1.25cm depth.This reflects the perfusion and the oxygen consumption in the free flap.
A control pediatric sensor is placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects the normal tissue oxygenation of the patient. NIRS uses this technology for the detection of ischemia and hypoxia. It is a real-time, continuous, non-invasive method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reliability of NIRS in DIEP flap surgery | – | Device: FORE-SIGHT ELITE monitorIn patients who underwent DIEP flap surgery, monitoring of postoperative tissue oxygen saturation of the flap by use of the FORE-SIGHT Elite monitor will be compared to standard of care physical examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women, over 18 years, undergoing unilateral or bilateral DIEP flap procedure
Key inclusion criteria (1 listed)
- scheduled for elective unilateral or bilateral breast reconstruction via DIEP flap procedure.
Key exclusion criteria (3 listed)
- refusal of written informed consent
- redo-surgery
- known history of allergy to adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FORE-SIGHT ELITE monitorAt end of surgery, one sensor of the FORE-SIGHT Elite monitor is placed on the DIEP flap or two sensors in case of bilateral DIEP flaps for monitoring perfusion and oxygen consumption in the free flap. A control sensor of the FORE-SIGHT Elite monitor placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects normal tissue oxygenation. Data obtained from the FORE-SIGHT Elite monitor will be compared to data obtained from physical examination, which is standard of care for flap monitoring. | Device | Reliability of NIRS in DIEP flap surgery |
Primary outcome
Detection of ischaemia after DIEP flap surgery by use of NIRS
Time frame: first 72 hours post surgery
The aim of the study is to determine whether near infrared spectrometry(NIRS) would be a validated tool to detect early microvascular complications. A decrease of 10% of the Sct O2 taken at the DIEP flap(s) compared to Sct O2 of the abdomen will be considered as possible risk of ischaemia.
Results and safety
The study was stopped early (reason given: It is practically not feasible to maintain the electrodes in place for 72 hours.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Saldien, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy and Breast Reconstruction, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It is practically not feasible to maintain the electrodes in place for 72 hours.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of ischaemia after DIEP flap surgery by use of NIRS (time frame: first 72 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.