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John F Kerin

Publications and source records attributed to John F Kerin.

5 recordsLinked to original sources
PubMed2004

Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system.

STUDY OBJECTIVE: To assess the safety and placement effectiveness of a new delivery catheter for the Essure micro-insert hysteroscopic sterilization system. DESIGN: Prospective, multicenter, single-arm clinical study. (Canadian Task Force classification II-3). SETTING: Hospital-based clinical research centers. PATIENTS: One hundred two women of reproductive age and proven fertility. INTERVENTION: A new coil catheter delivery system was used for micro-insert placement. MEASUREMENTS AND MAIN RESULTS: The bilateral placement of micro-inserts using the coil catheter delivery system occurred in 100 women out of 102 attempts (98%). The two women who did not have successful micro-insert placement were subsequently shown to have proximal tubal stenotic disease. CONCLUSION: These findings indicate that the introduction of the coil catheter delivery system for Essure hysteroscopic sterilization improves the micro-insert bilateral placement rate when compared with previous studies. It is hypothesized that the coil catheter has superior navigational properties, particularly within tortuous or narrowed tubal lumens.

Adult↗
PubMed2003

Microinsert nonincisional hysteroscopic sterilization.

OBJECTIVE: To assess the safety, effectiveness, and reliability of a tubal occlusion microinsert for permanent contraception, as well as to document patient recovery from the placement procedure and overall patient satisfaction. METHODS: A cohort of 518 previously fertile women seeking sterilization participated in this prospective, phase III, international, multicenter trial. Microinsert placement was attempted in 507 women. Microinserts were placed bilaterally into the proximal fallopian tube lumens under hysteroscopic visualization in outpatient procedures. RESULTS: Bilateral placement of the microinsert was achieved in 464 (92%) of 507 women. The most common reasons for failure to achieve satisfactory placement were tubal obstruction and stenosis or difficult access to the proximal tubal lumen. More than half of the women rated the average pain during the procedure as either mild or none, and 88% rated tolerance of device placement procedure as good to excellent. Average time to discharge was 80 minutes. Sixty percent of women returned to normal function within 1 day or less, and 92% missed 1 day or less of work. Three months after placement, correct microinsert placement and tubal occlusion were confirmed in 96% and 92% of cases, respectively. Comfort was rated as good to excellent by 99% of women at all follow-up visits. Ultimately, 449 of 518 women (87%) could rely on the microinsert for permanent contraception. After 9620 woman-months of exposure to intercourse, no pregnancies have been recorded. CONCLUSION: This study demonstrates that hysteroscopic interval tubal sterilization with microinserts is well tolerated and results in rapid recovery, high patient satisfaction, and effective permanent contraception.

Adult↗
PubMed2003

Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study.

BACKGROUND: Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated. METHODS: A cohort of 227 previously fertile women participated in this prospective international multicentre trial. Micro-inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization in outpatient procedures. RESULTS: Successful bilateral micro-insert placement was achieved in 88% of women. The majority of women reported that intraprocedural pain was less than or equal to that expected, and 90% rated tolerance of the device placement procedure as good to excellent. Most women could be discharged in an ambulatory state within 1-2 h. Adverse events occurred in 7% of the women, but none was serious. Correct device placement was confirmed in 97% of cases at 3 months. Over 24 months follow-up, 98% of study participants rated their tolerance of the micro-insert as very good to excellent. After 6015 woman-months of exposure to intercourse, no pregnancies have been recorded. CONCLUSIONS: Hysteroscopic sterilization resulted in rapid patient recovery without unacceptable post-procedure pain, as well as high long-term patient tolerability, satisfaction and effective permanent contraception.

Adult↗
PubMedDate not supplied

Ultrasound: an effective method for localization of the echogenic Essure sterilization micro-insert: correlation with radiologic evaluations.

STUDY OBJECTIVE: To examine the reliability and practicality of performing office-based transvaginal ultrasound for determining the ease of locating the Essure hysteroscopic sterilization micro-insert and compare its usefulness against established radiologic evaluations. DESIGN: Prospective single-center, single-arm, clinical study (Canadian Task Force classification xx). SETTING: Hospital-based clinical research center. PATIENTS: One hundred forty-five women of reproductive age and proven fertility. INTERVENTION: Thirty-seven women who underwent the Essure hysteroscopic method of sterilization had routine radiologic and transvaginal ultrasound assessments for determining the retention of these micro-inserts from 3 months to 2 years after placement. An additional 108 women had ultrasound assessment as the only means of micro-insert localization 3 months after placement. MEASUREMENTS AND MAIN RESULTS: The 145 women (100%) who underwent an ultrasound assessment at a 3-month, posthysteroscopic-sterilization office visit had their micro-inserts readily identified and localized to the uterotubal area due to the micro-inserts' dense echogenic properties. For the 37 women who had both assessments, the ultrasound findings correlated with pelvic radiograph and hysterosalpingogram assessments of micro-insert location in all instances. In addition, the ultrasound evaluations provided additional information about the micro-inserts relative position to the surrounding, less-echogenic soft tissue structures of the upper uterotubal area. In the 37 women who had serial ultrasound and radiologic evaluations performed for up to 2 years after micro-insert placement, ultrasound was found to be equally effective in identifying the location of the micro-inserts and indicted that their position remained identifiable and stable over time. CONCLUSION: A single transvaginal ultrasound in-office examination, performed 3 months after hysteroscopic micro-insert placement, was found to be a simple, reliable, and convenient method of assessing micro-insert location, when compared with radiologic assessments.

Ambulatory Surgical Procedures↗