A Phase 4 interventional study of Indocyanine Green and Standard clinical perfusion assessment in Head and Neck Cancer (H&N), Free Tissue Flaps and Free Flap, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Region Skane · Phase 4, Interventional, and Treatment
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Among 34 studies in Head and Neck Neoplasms with a site in Sweden — 10 open to participants now, 13 under way, 2 of them phase 3. Head and Neck Neoplasms · Sweden.
Among the 34 studies in Head and Neck Neoplasms with a site in Sweden, this one is the 12th largest by planned enrollment of the 26 interventional ones that give a count, is one of 3 that started in 2026, is one of 2 in phase 4, reaches primary completion later than 10 of the 12 other live ones, and was the 32nd registered.
2,713 studies on the registry are indexed under Head and Neck Neoplasms; 596 are open to participants now.
Browse Head and Neck Neoplasms studies →10 of the 34 studies in Head and Neck Neoplasms with a site in Sweden are open now. Recruiting first, the newest first:
OncoZenge AB · Sites in Sweden, Denmark, Germany and 1 more country
Ages 18–80
Karolinska University Hospital · Sites in Sweden
Ages 18+
Uppsala University · Sites in Sweden
Ages 18+
Lars Olaf Cardell · Sites in Sweden
Ages 18+
GlaxoSmithKline · Sites in Sweden, United States, Argentina and 28 more countries
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 3 · Phase 3 10 · Phase 4 2
First in 2003; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 244 is above the median of 46 across 2,033 interventional studies indexed under Head and Neck Neoplasms.
Median enrollment 187 across the 26 interventional studies, 119 across the 8 observational. Of the 20 that completed or were terminated, 9 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 34 have an industry lead sponsor. The 10 most frequent:
Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Region Skane has 3 studies filed under Head and Neck Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Head and Neck Neoplasms with a site in Sweden that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07672236Phase 3OncoZenge ABA Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer. | 2026-12-23 |
| NCT03481647Göteborg UniversityEvaluation of an Oral Care Programme for Head and Neck Cancer Patients | 2026-12-31 |
| NCT06639191Karolinska University Hospital[177Lu]Lu-AKIR001 First-in-human Study | 2027-11-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 34 studies in Head and Neck Neoplasms with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.
The VISION Trial is a prospective, multicentre, open-label, parallel-group randomised controlled trial comparing intraoperative indocyanine green (ICG) fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.
Free flap reconstruction is an essential component of complex head and neck reconstruction, but flap survival depends on adequate microvascular perfusion. Conventional intraoperative assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination, provide indirect assessment of perfusion and may be unreliable in some situations.
ICG fluorescence angiography enables real-time visualisation of arterial inflow and venous outflow using near-infrared fluorescence imaging. Retrospective studies have suggested that ICG angiography may reduce rates of partial flap loss and flap-related re-exploration, but high-quality prospective randomised evidence remains limited.
A total of 244 adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects at participating Swedish centres will be included. Participants will be randomised to either standard clinical assessment alone or standard clinical assessment supplemented with intraoperative ICG fluorescence angiography.
In the intervention group, ICG angiography will be performed intraoperatively using near-infrared fluorescence imaging systems after administration of intravenous indocyanine green (Verdye®). Quantitative perfusion analysis will also be performed using SPY-Q software.
The primary endpoint is partial flap loss requiring intervention within 30 days after surgery. Secondary endpoints include total flap loss, flap-related re-exploration under general anaesthesia, flap salvage, postoperative complications graded according to Clavien-Dindo classification, and the association between intraoperative SPY-Q perfusion values and flap outcomes.
No additional trial-specific postoperative visits are required. Outcomes will be assessed through structured chart review at 30 and 90 days postoperatively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo intraoperative assessment of free flap perfusion using standard clinical assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated. Surgical revision is performed according to standard clinical practice if inadequate perfusion is suspected.
Procedure: Standard clinical perfusion assessment
Participants undergo intraoperative assessment of free flap perfusion using indocyanine green (ICG) fluorescence angiography in addition to standard clinical assessment. ICG is administered intravenously and perfusion is evaluated using near-infrared fluorescence imaging and SPY-Q quantitative perfusion analysis during head and neck free flap reconstruction.
Drug: Indocyanine Green · Procedure: Standard clinical perfusion assessment
Indocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction. A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush. Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis.
Also known as: ICG, Verdye
Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.
Partial flap loss requiring intervention
Partial flap loss is defined as clinically evident flap necrosis requiring active therapeutic intervention, including operative debridement/revision in the operating room or bedside debridement/trimming performed by a surgeon beyond routine wound care.
Time frame: From index surgery to 30 days postoperatively
Total flap loss
Complete flap failure requiring flap removal, replacement, or abandonment with documentation of flap non-viability.
Time frame: From index surgery to 30 days postoperatively
Flap-related re-exploration under general anaesthesia
Return to the operating room under general anaesthesia due to suspected or confirmed flap vascular compromise or flap viability concern, excluding planned second-look procedures without concern.
Time frame: From index surgery to 30 days postoperatively
Flap salvage
Successful retention of the index flap following flap-related re-exploration for vascular compromise.
Time frame: From index surgery to 30 days postoperatively
Postoperative complications
Incidence of postoperative complications occurring 90 days after index operation. Predefined surgical complications will be captured systematically and include surgical takeback, partial flap loss, total flap loss, infection, hematoma or bleeding requiring intervention, fistula formation, wound dehiscence, seroma, abnormal wound healing, and other surgical complications. The severity of complications will be classified according to the Clavien-Dindo Classification of Surgical Complications (Grade I-V, where Grade I represents the least severe complication and Grade V represents death).
Time frame: From index surgery to 90 days postoperatively
Correlation between intraoperative SPY-Q Relative Perfusion Value (%) and partial flap loss
Correlation between intraoperative tissue perfusion measured using SPY-Q quantitative analysis software following indocyanine green fluorescence angiography and postoperative partial flap loss within 30 days after surgery. SPY-Q Relative Perfusion Value is reported as a percentage ranging from 0% to 100%, where higher values indicate greater tissue perfusion. Partial flap loss is assessed clinically and recorded as a binary outcome (present or absent). The outcome measure is the correlation coefficient between SPY-Q Relative Perfusion Value and partial flap loss.
Time frame: From index surgery to 30 days postoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2029, 27 months later.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Indocyanine Green