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Prolapse clinical trials

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NCT ID: NCT03055819 Terminated - Senile Ptosis Clinical Trials

Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study

LIFT
Start date: February 3, 2017
Phase: N/A
Study type: Interventional

The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations

NCT ID: NCT02878694 Terminated - Ptosis Clinical Trials

Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft

TTT-PT-DOP
Start date: November 14, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Interventional , multicenter , comparative study. One eye receiving the cells and the contralateral eye as a negative control . If effectiveness following review of the primary endpoint and the advice of an independent expert committee , the experimental treatment will be offered to the patient to the contralateral eyelid. Objective is to restore muscle function levator muscle of the upper eyelid by providing a registry of autologous myoblasts from a non- clinically affected muscle .

NCT ID: NCT02739256 Terminated - Clinical trials for Pelvic Organ Prolapse

Early Versus Late Voiding Trials After Prolapse Repair

Start date: February 2016
Phase: N/A
Study type: Interventional

The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.

NCT ID: NCT02162628 Terminated - Clinical trials for Pelvic Organ Prolapse

Exair® Versus Native Tissue Repair for Prolapse

Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.

NCT ID: NCT02123992 Terminated - Clinical trials for Pelvic Organ Prolapse

Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse

Harmony 522
Start date: April 2014
Phase: Phase 4
Study type: Interventional

The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.

NCT ID: NCT02121977 Terminated - Clinical trials for Pelvic Organ Prolapse

Study of the Elevate Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse

Embrace
Start date: April 2014
Phase: Phase 4
Study type: Interventional

The aim of this study is to further evaluate the safety and efficacy of the Elevate® Anterior and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a controlled, post-market cohort study.

NCT ID: NCT01886794 Terminated - Clinical trials for Pelvic Floor Disorders

Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Start date: June 6, 2013
Phase: Phase 4
Study type: Interventional

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

NCT ID: NCT01673360 Terminated - Clinical trials for Pelvic Organ Prolapse

Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

CAPTURE
Start date: September 2012
Phase: N/A
Study type: Observational

To monitor post-market performance through evaluation of short and long-term performance via: - Efficacy - Safety - Patient reported outcomes

NCT ID: NCT01595412 Terminated - Rectal Prolapse Clinical Trials

An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy With Laparoscopic Resection Rectopexy

LaProS
Start date: January 2010
Phase: N/A
Study type: Interventional

Background: Rectal prolapse (RP) is the descent of the upper rectum and is a common problem in the western world. Surgery is the only definite treatment and is preferably performed minimally invasive. High-level prospective studies on treatment strategies for RP currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with RP. Furthermore, remarkable transatlantic differences exist, as in Europe, laparoscopic ventral rectopexy (LVR) is regarded the treatment of choice, while in the USA Laparoscopic Resection Rectopexy (LRR) remains the golden standard. Objective: To determine the optimal minimally invasive surgical treatment for patients with RP. Design: International, prospective, comparative double cohort study. The first cohort will consist of 120 European patients with a RP and will be treated with LVR. Centres in The Netherlands, Belgium and the UK are enlisted for participation. The second cohort will consist of 120 American patients with a RP, treated with LRR. Several US centres are enlisted. Preoperative work-up consists of radiological imaging and standardised questionnaires. Follow-up (FU) is set on two years. During FU, pre-operative imaging and questionnaires will be repeated. Primary & secondary outcomes: Primary endpoint will be improvement on the Gastro-Intestinal-Quality-of-Life-Index (GIQLI). Secondary endpoints will be generic Quality-of-Life, functional results, morbidity, mortality, recurrences and cost-effectiveness. Time frame: Study and inclusion start will be on January the 1st, 2011 and will take approximately 18-24 months. Therefore, total study duration will be 42-48 months.

NCT ID: NCT01594372 Terminated - Uterine Prolapse Clinical Trials

Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Start date: January 2013
Phase: N/A
Study type: Interventional

Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.