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Bronchoscopic lung mapping using dye and microcoil

Bronchoscopic lung mapping using dye and microcoil to resect small pulmonary lesions: an open-label, uncontrolled, single-arm multi-center study - VAL-MAP 2.0

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180099
Enrollment
65
Registered
2019-02-01
Start date
2019-02-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pulmonary tumor (suspected or confirmed)

Interventions

Bronchoscopic lung mapping(Indigocarmine and microcoil) before lung surgery

Sponsors

Sato Masaaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Malignant pulmonary tumor (suspected or confirmed) that necessitates resection lines other than usual interlobar fissure 2) Corresponds to both 2-1 and 2-2 2-1) A pulmonary lesion or lesions that is anticipated to be hardly identifiable during surgery and necessitate careful determination of resection lines to obtain sufficient resection margins 2-2) A pulmonary lesion or lesions which the use of microcoil is considered to advantageous 3) Consent obtained from the patient

Exclusion criteria

Exclusion criteria: 1) Allergic to platinum 2) Allergic to indigo carmine 3) Anticipated difficulty in intra-airway placement of the microcoil 4) Pregnant women 5) Those who are difficult to obtain Informed Consent from or those aged less than 20 years old 6) Bronchoscopy and/or marking procedure is not feasible due to complications 7) Anatomy precludes successful resection defined in this study 8) Other reasons that are judged to be appropriate by a participating surgeon/physician in this study

Design outcomes

Primary

MeasureTime frame
Successful resection of pulmonary lesions with sufficient resection margins

Secondary

MeasureTime frame
Efficacy of lung mappings utilizing microcoil Efficacy of mapping-assisted surgery Safety

Contacts

Public ContactMasaaki Sato

The University of Tokyo Hospital

satom-sur@h.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026