Skip to content

High selective noninvasive laser in suppressing infantile venous malformations:a prospective, multi-centered, randomized controlled clinical trial

High selective noninvasive laser in suppressing infantile venous malformations:a prospective, multi-centered, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009651
Enrollment
Unknown
Registered
2016-10-27
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

venous malformation

Interventions

Laser Treatment:Long pulse Nd:YAG 1064nm
Control:No treatment (waiting list)

Sponsors

Shanghai 9th People's Hospital Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Patients that were diagnosed as venous malformation, according to ISSVA diagnosis and the diagnostic criteria included children with skin lesions venous malformation; 2. The depth of the lesion was less than 1cm; 3. Start treatment at the age of <3 years old; 4. Never received other treatment; 5. The parents signed informed consent, willing to accept the blank control test, and combined with the self - control with long-term trials, and with long-term follow-up.

Exclusion criteria

Exclusion criteria: 1. The presence of contraindications for laser; 2. The lesions in the short term rapid expansion, need surgery or interventional treatment; 3. The lesions were ulcer, infection and eczema; 4. The lesions caused serious or life-threatening dysfunction in children; 5. Other clinical trials of the patients received nearly three months.

Design outcomes

Primary

MeasureTime frame
MRI;

Secondary

MeasureTime frame
Micro-ultrasound imaging;Visual analogue scale(VAS);Photometer measurement;

Countries

China

Contacts

Public ContactXiaoxi Lin

Shanghai 9th People's Hospital, Shanghai Jiaotong University, School of Medicine

linxiaoxi@126.com+86 13701997136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026