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Leiomyoma clinical trials

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NCT ID: NCT01563783 Completed - Uterine Fibroids Clinical Trials

Post Market TRUST Study

TRUST
Start date: December 2012
Phase: N/A
Study type: Interventional

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.

NCT ID: NCT01555073 Terminated - Uterine Fibroids Clinical Trials

Preemptive Analgesia Following Uterine Artery Embolization

Start date: October 2011
Phase: Phase 4
Study type: Interventional

Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has been hysterectomy in post child bearing woman. However, over the last decade, the use of a minimal invasive technique called uterine artery embolization has become increasingly popular due to high patient satisfaction, cost effectiveness, and shorter recovery period. The purpose of this randomized blinded placebo controlled study is to compare pre-emptive analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term pain control, and improved quality of life in woman following uterine artery embolization surgery. The study consists of four drug groups including a placebo group. The addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as leading to a better post-procedure outcome in women following uterine artery embolization. Many investigators believe that the ischemia in the normal myometrium is the primary source of pain immediately following surgery making postoperative pain management challenging. Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to being an effective analgesic for chronic pain syndromes, the use of pregabalin provides effective postoperative analgesia when it is administered pre-emptively before an operation. Preemptive analgesia involves the introduction of an analgesic regimen before the onset of noxious stimuli, with the goal of preventing sensitization of the nervous system to subsequent stimuli that could amplify pain. In human trials, pregabalin has been demonstrated to reduce pain, improve sleep, and mood disturbances in patients with post herpetic neuralgia. The use of celecoxib in combination with pregabalin has shown to provide more effective analgesia by providing antihyperalgesia. Therefore, the addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as having an effect on long term sequelae.

NCT ID: NCT01553123 Withdrawn - Leiomyomas Clinical Trials

Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

Start date: April 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.

NCT ID: NCT01542658 Completed - Uterine Myoma Clinical Trials

Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy

Start date: February 2012
Phase: N/A
Study type: Observational

This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative variables and short-term outcome of RALM and TLM patients.

NCT ID: NCT01539187 Terminated - Uterine Fibroids Clinical Trials

Fibroid Ablation Study - Large Fibroids

FAST-L
Start date: June 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.

NCT ID: NCT01530802 Completed - Leiomyoma Clinical Trials

Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

Start date: January 2007
Phase: N/A
Study type: Interventional

The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly.

NCT ID: NCT01514617 Active, not recruiting - Leiomyomas Clinical Trials

Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization

Start date: January 2012
Phase: N/A
Study type: Interventional

It is known that volumetric response of leiomyomas following uterine artery embolization correlates well with patients clinical outcome. The aim of this study is to assess diffusion -and perfusion weighted MRI for the prediction of volumetric response following uterine artery embolization in patients with symptomatic leiomyomas.

NCT ID: NCT01504308 Terminated - Uterine Fibroids Clinical Trials

Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

SOFIA
Start date: May 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

NCT ID: NCT01492179 Completed - Uterine Cancer Clinical Trials

Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.

PoPuLAR
Start date: November 2011
Phase: Phase 4
Study type: Interventional

Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.

NCT ID: NCT01483417 Recruiting - Uterine Myoma Clinical Trials

Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Start date: December 2011
Phase: Phase 3
Study type: Interventional

Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.