Clinical Trials Logo
  1. Home
  2. Atrophy
  3. NCT02868749

Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

Atrophy Clinical Trial

Official title:
Comparative Clinical, Histological and Ultrasound Pilot Study of Two Hyaluronic Acid Gel Fillers, Designed for Deep Injection, in Adipose Tissue

Clinical Trial Summary

This study is a single-blind intra-individual comparative study to evaluate the short and medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA), designed for deep injection, that have been used for several years on a worldwide scale.

Clinical Trial Description

The study will be disclosed to patients who present with an indication for either abdominoplasty or bilateral breast reduction with a Wise pattern skin excision (inverted T inframammary scar) Informed consent will be obtained from volunteers at their next consultation, during which the preoperative preparation is finalised and the surgery is booked.

Participants will receive injections for the first time three weeks to four months before the operation and for the second time five to nine days before the operation, in tissue that will be removed during the surgery.

In each session, through one single access point, a linear retrograde, subcutaneous injection will be performed with 0,5 ml of each of the studied hyaluronic acid gels, each in an opposite direction, each parallel to the skin surface.

Both sessions will be monitored by ultrasound examination. After the injections, the 2 cm of injected area which is most remote from the entrance point of the cannula will be remodelled by finger pressure and tissue pinching, to simulate remodelling as commonly performed after filler injection.

At the beginning of the operation, the injected subcutaneous fat will be removed with the overlying skin, to be sent for histologic examination.

The objective of the histologic examination is to assess the tissue response at one week versus three weeks to four months after the injection, as well as to assess the spread of the products, with and without remodelling after injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02868749
Study type Interventional
Source Vandeputte, Joan, M.D.
Contact
Status Completed
Phase N/A
Start date March 22, 2017
Completion date September 30, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT02781623 - Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
Completed NCT02497547 - An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy Phase 2
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT00566982 - A Clinical Study to Evaluate the Safety of Ospemifene Phase 3
Completed NCT01586364 - Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus Phase 3
Active, not recruiting NCT05698316 - A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression
Recruiting NCT05869812 - Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes Phase 2
Completed NCT02770365 - Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy Phase 3
Completed NCT02747641 - Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects N/A
Recruiting NCT02137824 - A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients N/A
Completed NCT01585558 - Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus Phase 3
Recruiting NCT01911312 - Evaluation of Thermal-Aided Muscle Stimulation N/A
Completed NCT00729469 - Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity Phase 3
Completed NCT01553773 - Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment Phase 2
Recruiting NCT02745366 - Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction Phase 1
Completed NCT00744094 - Resistance Training in Elderly Phase 1/Phase 2
Completed NCT00807508 - Leucine Supplementation in Elderly Men Phase 1/Phase 2
Terminated NCT00292916 - Effect of Whole Body Vibration on Bone and Fall Related Parameters Phase 3
Terminated NCT00267839 - Effect of Exercise on Risk-factors of Elderly Women Phase 3
Completed NCT00276094 - A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3